| Primary | Number of Participants With Major Adverse Events | A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastro-intestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood. | Intent-To-Treat Population set (ITT) | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG002 | High Risk | Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG003 | Non-high RIsk | Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
| | Units | Counts |
|---|
| Participants | - OG00059
- OG0017
- OG002628
- OG003
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| | Title | Denominators | Categories |
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| Primary | Number of Participants With Major Adverse Events | A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood. | | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Primary | Number of Participants With 12-Month Efficacy | Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR > 2+ (moderate to severe (3+) or severe MR (4+)). | Analysis was performed in 52 participants out of 59 in CU arm, in 6 subjects out of 7 in EU arm, in 556 participants out of 628 participants and 248 out of 271 participants in non-HR arm were analyzed. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With Serious Adverse Events | The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization. | | Posted | | Number | | participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With Serious Adverse Events | The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization. | | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With Clinically Significant Atrial Septal Defect (ASD) | Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD. | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With Clinically Significant Atrial Septal Defect (ASD) | Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD. | | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age | MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age. | CU Arm: There are 27 patients >75 years old in the CU arm. Safety data are available only for 26 patients. EU Arm: There are 5 patients >75 years old in the EU arm. HR arm: There are 393 patients >75 years old in the HR arm. Non-HR arm: There are 140 patients >75 years old in the Non-HR arm. | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use |
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| Secondary | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age. | CU Arm: There are 27 patients >75 years old in the CU arm. Safety data are available only for 26 patients. EU Arm: There are 5 patients >75 years old in the EU arm. HR arm: There are 393 patients >75 years old in the HR arm. Non-HR arm: There are 140 patients >75 years old in the Non-HR arm. | Posted | | Count of Participants | | Participants | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use |
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| Secondary | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age. | CU Arm: There are 27 patients >75 years old in the CU arm. Safety data are available only for 26 patients. EU Arm: There are 5 patients >75 years old in the EU arm. HR arm: There are 393 patients >75 years old in the HR arm. Non-HR arm: There are 140 patients >75 years old in the Non-HR arm. | Posted | | Count of Participants | | Participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use |
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| Secondary | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age. | CU Arm: There are 27 patients >75 years old in the CU arm. Safety data are available only for 26 patients. EU Arm: There are 5 patients >75 years old in the EU arm. HR arm: There are 393 patients >75 years old in the HR arm. Non-HR arm: There are 140 patients >75 years old in the Non-HR arm. | Posted | | Count of Participants | | Participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use |
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| Secondary | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age. | CU Arm: There are 27 patients >75 years old in the CU arm. Safety data are available only for 24 patients. EU Arm: There are 5 patients >75 years old in the EU arm. HR arm: There are 393 patients >75 years old in the HR arm. Non-HR arm: There are 140 patients >75 years old in the Non-HR arm. | Posted | | Count of Participants | | Participants | | 4 years | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use |
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| Secondary | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age. | CU Arm: There are 27 patients >75 years old in the CU arm. Safety data are available only for 24 patients. EU Arm: There are 5 patients >75 years old in the EU arm. HR arm: There are 393 patients >75 years old in the HR arm. Non-HR arm: There are 140 patients >75 years old in the Non-HR arm. | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use |
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| Secondary | Number of Participants With Acute Procedural Success | Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ or less as determined by the echocardiographic assessment at discharge. The 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or uninterpretable, providing the patient has not undergone subsequent surgery after attempted clip. | | Posted | | Count of Participants | | Participants | | At discharge (an average of ≤ 12.3 days post-index procedure) | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With Procedural Success | Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA at 30 days. | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With Clinical Durability | Defined as the proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that at 12 months have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA at 12 months. | | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With Clip Implant Rate | Defined as the procedural rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter. | | Posted | | Count of Participants | | Participants | | On the day of index procedure (≤1 day) | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Procedure Time | The mean procedure time is defined as the start time of the transseptal procedure to the time the steerable guide catheter (SGC) is removed. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | minutes | | On the day of index procedure | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Device Time | Device time is defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip delivery catheter is retracted into the SGC. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | minutes | | On the day of index procedure | | | | ID | Title | Description |
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| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Fluoroscopy Duration | Mean fluoroscopy duration during the MitraClip procedure. | | Posted | | Mean | Standard Deviation | minutes | | On the day of index procedure | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With MitraClip Devices Implanted | The distribution of number of MitraClip devices implanted in patients. | | Posted | | Count of Participants | | Participants | | On the day of index procedure | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration | Defined as the number of hours for which patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit. | | Posted | | Mean | Standard Deviation | Hours | | At discharge (an average of ≤ 12.3 days post-index procedure). | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Post-Procedure Length of Hospital Stay | Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility. | | Posted | | Mean | Standard Deviation | Days | | At discharge (an average of ≤ 12.3 days post-index procedure). | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants Experiencing Death | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Non-cardiac death is defined as a death not due to cardiac causes (as defined above). | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Count of Participants | | Participants | | 12 months visit window (410 days) | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | |
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| Secondary | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | | | Posted | | Count of Participants | | Participants | | At discharge (an average of ≤ 12.3 days post-index procedure) | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With Hospital Re-admissions | Defined as re-admission of patients to the hospital following discharge from the Clip procedure. | | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA) | A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. | | Posted | | Count of Participants | | Participants | | 0 to 5 years | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With Mitral Stenosis | Mitral stenosis is a key safety consideration assessed after implantation of the MitraClip device. It is defined as Mitral Valve Area (MVA) less than 1.5 cm^2 as assessed by the Echocardiography Core Laboratory (ECL). | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Count of Participants | | Participants | | 0 to 5 years | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With Mitral Regurgitation (MR) Severity | Paired site-assessed Mitral regurgitation severity between baseline and 30 days using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Count of Participants | | Participants | | 30 days(Follow-up) | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With MR Severity | Paired site-assessed Mitral regurgitation severity between baseline and 12 months using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With MR Severity | Paired site-assessed Mitral regurgitation severity between baseline and 2 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Count of Participants | | Participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With MR Severity | Paired site-assessed Mitral regurgitation severity between baseline and 3 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Count of Participants | | Participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With MR Severity | Paired site-assessed Mitral regurgitation severity between baseline and 4 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe. | The 4-year visit was optional and no data were collected at this time point for CU and EU arm. The number of participants analyzed includes subjects who had available follow up data at that time frame in HR and Non-HR arm. | Posted | | Count of Participants | | Participants | | 4 years | | | | ID | Title | Description |
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| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With MR Severity | Paired site-assessed Mitral regurgitation severity between baseline and 5 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With Second Intervention to Place an Additional Mitraclip Device. | If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered. | | Posted | | Count of Participants | | Participants | | 139 days post the index procedure | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With Second Intervention to Place an Additional Mitraclip Device. | If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered. | | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With New York Heart Association (NYHA) Functional Class | Paired NYHA data from baseline to 30 days. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Count of Participants | | Participants | | 30 days | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With NYHA Functional Class | Paired NYHA data from baseline to 12 months. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With NYHA Functional Class | Paired NYHA data from baseline to 2 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Count of Participants | | Participants | | 2 years | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With NYHA Functional Class | Paired NYHA data from baseline to 3 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Count of Participants | | Participants | | 3 years | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Number of Participants With NYHA Functional Class | Paired NYHA data from baseline to 4 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | The 4-year visit was optional and no data were collected at this time point for CU and EU arm. The number of participants analyzed includes subjects who had available follow up data at that time frame in HR and Non-HR arm. | Posted | | Count of Participants | | Participants | | 4 years | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Number of Participants With NYHA Functional Class | Paired NYHA data from baseline to 5 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Count of Participants | | Participants | | 5 years | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular End-diastolic Volume (LVEDV) | Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to discharge or 30 days as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | ml | | At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular End-diastolic Volume (LVEDV) | Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 12 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | ml | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular End-diastolic Volume (LVEDV) | Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 24 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | ml | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular End-diastolic Volume (LVEDV) | Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 36 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | ml | | 36 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular End-diastolic Volume (LVEDV) | Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 48 months as determined by the echo core laboratory. | For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | ml | | 48 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular End-diastolic Volume (LVEDV) | Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 60 months as determined by echo core laboratory. | For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | ml | | 60 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular End-systolic Volume (LVESV) | Paired Left ventricular end-systolic volume (LVESV) data from baseline to discharge or 30 days as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | ml | | At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular End-systolic Volume (LVESV) | Paired Left ventricular end-systolic volume (LVESV) data from baseline to 12 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | ml | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular End-systolic Volume (LVESV) | Paired Left ventricular end-systolic volume (LVESV) data from baseline to 24 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | ml | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular End-systolic Volume (LVESV) | Paired Left ventricular end-systolic volume (LVESV) data from baseline to 36 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | ml | | 36 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular End-systolic Volume (LVESV) | Paired Left ventricular end-systolic volume (LVESV) data from baseline to 48 months as determined by echo core laboratory. | For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | ml | | 48 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular End-systolic Volume (LVESV) | Paired Left ventricular end-systolic volume (LVESV) data from baseline to 60 months as determined by echo core laboratory. | For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | ml | | 60 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Internal Dimension Diastole (LVIDd) | Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to discharge or 30 days as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Internal Dimension Diastole (LVIDd) | Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 12 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Internal Dimension Diastole (LVIDd) | Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 24 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Internal Dimension Diastole (LVIDd) | Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 36 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 36 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Internal Dimension Diastole (LVIDd) | Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 48 months as determined by echo core laboratory. | For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 48 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Internal Dimension Diastole (LVIDd) | Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 60 months as determined by echo core laboratory. | For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 60 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Internal Dimension Systole (LVIDs) | Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to discharge or 30 days as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Internal Dimension Systole (LVIDs) | Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 12 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Internal Dimension Systole (LVIDs) | Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 24 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Internal Dimension Systole (LVIDs) | Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 36 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 36 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Internal Dimension Systole (LVIDs) | Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 48 months as determined by echo core laboratory. | For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 48 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Internal Dimension Systole (LVIDs) | Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 60 months as determined by echo core laboratory. | For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 60 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Ejection Fraction (LVEF) | Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to discharge or 30 days as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | percentage of ejection fraction | | At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Ejection Fraction (LVEF) | Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 12 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | percentage of ejection fraction | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Ejection Fraction (LVEF) | Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 24 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | percentage of ejection fraction | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Ejection Fraction (LVEF) | Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 36 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | percentage of ejection fraction | | 36 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Ejection Fraction (LVEF) | Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 48 months as determined by echo core laboratory. | For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | percentage of ejection fraction | | 48 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Left Ventricular Ejection Fraction (LVEF) | Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 60 months as determined by echo core laboratory. | For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | percentage of ejection fraction | | 60 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Septal-Lateral Annular Dimension Diastole (SLADd) | Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to discharge or 30 days as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Septal-Lateral Annular Dimension Diastole (SLADd) | Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 12 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Septal-Lateral Annular Dimension Diastole (SLADd) | Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 24 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Septal-Lateral Annular Dimension Diastole (SLADd) | Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 36 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 36 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Septal-Lateral Annular Dimension Diastole (SLADd) | Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 48 months as determined by echo core laboratory. | For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 48 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Septal-Lateral Annular Dimension Diastole (SLADd) | Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 60 months as determined by echo core laboratory. | For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 60 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Septal-Lateral Annular Dimension Systole (SLADs) | Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to discharge or 30 days as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Septal-Lateral Annular Dimension Systole (SLADs) | Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 12 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
|
| Secondary | Septal-Lateral Annular Dimension Systole (SLADs) | Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 24 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Septal-Lateral Annular Dimension Systole (SLADs) | Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 36 months as determined by echo core laboratory. | The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 36 months | | | | ID | Title | Description |
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| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Septal-Lateral Annular Dimension Systole (SLADs) | Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 48 months as determined by echo core laboratory. | For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 48 months | | | | ID | Title | Description |
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| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Secondary | Septal-Lateral Annular Dimension Systole (SLADs) | Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 60 months as determined by echo core laboratory. | For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | cm | | 60 months | | | | ID | Title | Description |
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| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Emergency Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Other Pre-specified | 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days | The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts:
- Physical functioning
- Role limitations due to physical or
- Emotional health
- Bodily pain
- General health perceptions
- Vitality
- Social functioning
- General mental health
Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively. | EU arm participants were not analyzed due to the serious/life-threatening conditions,SF-36 QOL data was not collected on all patients at baseline. Therefore, paired data at 30 days were not available for EU arm. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | Scores on a scale | | 30 days | | | | ID | Title | Description |
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| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Other Pre-specified | 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months | The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts:
- Physical functioning
- Role limitations due to physical or
- Emotional health
- Bodily pain
- General health perceptions
- Vitality
- Social functioning
- General mental health
Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively. | EU arm participants were not analyzed due to the serious/life-threatening conditions, QOL data was not collected on all patients at baseline. Therefore, paired data at 1 year were not available for EU arm. The number of participants analyzed includes subjects who had available follow up data at that time frame. | Posted | | Mean | Standard Deviation | Scores on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Other Pre-specified | Change in 6-Minute Walk Test (6MWT) | Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes. | EU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore,paired data at 30 days were not available for EU arm. The number of participants analyzed includes subjects who had available follow up data at that time frame in CU, HR and Non-HR arms. | Posted | | Mean | Standard Deviation | Meters | | At Baseline and 30 Days | | | | ID | Title | Description |
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| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | High Risk | Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Other Pre-specified | Change in 6-Minute Walk Test (6MWT) | Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes. | EU and CU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore, paired data at 6 months were not available for EU and CU arm. The number of participants analyzed includes subjects who had available follow up data at that time frame HR and Non-HR arms. | Posted | | Mean | Standard Deviation | Meters | | At Baseline and 6 months | | | | ID | Title | Description |
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| OG000 | High Risk | Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | Non-high Risk | Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk). If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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| Other Pre-specified | Change in 6-Minute Walk Test (6MWT) | Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes. | EU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore, paired data at 1 year were not available for EU arm. The number of participants analyzed includes subjects who had available follow up data at that time frame in CU, HR and Non-HR arms. | Posted | | Mean | Standard Deviation | Meters | | At Baseline and 12 months | | | | ID | Title | Description |
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| OG000 | Compassionate Use | Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | | OG001 | High Risk | Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. |
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