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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol #0301 |
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Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System.
The study is a prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. A minimum of 20 patients will be enrolled (an additional maximum of 12 roll in-patients, a maximum of 2 per site, may be enrolled and analyzed separately). Patients will undergo 30-day, 6 month and 12 month clinical follow-up.
Up to 12 clinical sites throughout the US may participate.
The primary endpoint is acute safety at thirty days, with a secondary efficacy endpoint of reduction of MR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MitraClip | Experimental | Percutaneous mitral valve repair (MitraClip Implant) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous mitral valve repair (MitraClip Implant) | Device | Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System. |
| Measure | Description | Time Frame |
|---|---|---|
| Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | At baseline |
| Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | At discharge or within 30 days of the procedure |
| Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | At 12 months |
| Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | At 24 months |
| Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Time | Procedure Time, defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter (SOC) is removed, averaged 255 minutes, or just over 4 hours. The reported Procedure Time includes the time required to collect Protocol required hemodynamic data pre- and post-implantation of the MitraClip device. | At day 0 (on the day of index procedure) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ted Feldman, M.D. | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evanston Northwestern Healthcare | Evanston | Illinois | 60201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14530193 | Background | St Goar FG, Fann JI, Komtebedde J, Foster E, Oz MC, Fogarty TJ, Feldman T, Block PC. Endovascular edge-to-edge mitral valve repair: short-term results in a porcine model. Circulation. 2003 Oct 21;108(16):1990-3. doi: 10.1161/01.CIR.0000096052.78331.CA. Epub 2003 Oct 6. | |
| 15302782 | Background | Fann JI, St Goar FG, Komtebedde J, Oz MC, Block PC, Foster E, Butany J, Feldman T, Burdon TA. Beating heart catheter-based edge-to-edge mitral valve procedure in a porcine model: efficacy and healing response. Circulation. 2004 Aug 24;110(8):988-93. doi: 10.1161/01.CIR.0000139855.12616.15. Epub 2004 Aug 9. |
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Patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation determined from a transthoracic echocardiogram (TTE), who were candidates for mitral valve (MV) surgery and cardiopulmonary bypass were considered for enrollment in this study.
A total of 55 EVEREST I patients were enrolled at 11 sites.The first EVEREST I patient was enrolled on July 2, 2003 and the last patient was enrolled on February 15, 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Percutaneous Mitral Valve Repair (MitraClip Implant) | Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
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| At 12 Months Follow-up |
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| At 24 Months Follow-up |
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| At 3 Years Follow-up |
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| At 4 Years Follow-up |
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| At 5 Years Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Percutaneous Mitral Valve Repair (MitraClip Implant) | Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | Of total 55 patients,for 1 patient Echocardiogram was not evaluable. | Posted | Number | Percentage of participants | At baseline |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Percutaneous Mitral Valve Repair (MitraClip Implant) | Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey T Ellis | Abbott Vascular | jeffrey.ellis@av.abbott.com |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D008945 | Mitral Valve Prolapse |
| D003324 | Coronary Artery Disease |
| D006333 | Heart Failure |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D016127 | Heart Valve Prolapse |
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| At 3 years |
| Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | At 4 years |
| Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | At 5 years |
| Major Adverse Events (MAE) | Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia. | Through 30 days |
| Major Adverse Events (MAE) | Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia. | Through 6 Months |
| Device Time | Device Time, defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip Delivery Catheter is retracted into the SGC. | At day 0 (on the day of index procedure) |
| Contrast Volume | Mean contrast volume utilized during the MitraClip procedure. | At day 0 (on the day of index procedure) |
| Fluoroscopy Duration | Mean fluoroscopy duration during the MitraClip procedure. | At day 0 (on the day of index procedure) |
| Number of Mitraclip Devices Implanted | At day 0 (on the day of index procedure) |
| Intra-procedural Major Adverse Events | Significant intra-procedural Major adverse events are defined as Major Adverse Events that occurred on the day of the procedure | At day 0 (on the day of index procedure) |
| Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration | Post index procedure within 30 days |
| Post-procedure Hospital Stay | Post-index procedure until hospital discharge (1 to 19 days) |
| Second Intervention to Place a Second MitraClip Device | Post index procedure through 5 years |
| MitraClip Device Embolizations and Single Leaflet Device Attachment | MitraClip device embolizations means the detachment from both mitral leaflets. Single Leaflet Device Attachment (SLDA) is defined as the attachment of a single leaflet to the MitraClip device. | Post index procedure through 5 years |
| Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | At baseline |
| Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | At 12 months |
| Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | At 24 months |
| Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | At 3 Years |
| Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | At 4 Years |
| Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | At 5 Years |
| Death (Kaplan-Meier Freedom From Death) | Within 30 days of the procedure |
| Death (Kaplan-Meier Freedom From Death) | At 12 months |
| Death (Kaplan-Meier Freedom From Death) | At 24 months |
| Death (Kaplan-Meier Freedom From Death) | At 3 years |
| Death (Kaplan-Meier Freedom From Death) | At 4 years |
| Death (Kaplan-Meier Freedom From Death) | At 5 years |
| Major Vascular and Bleeding Complications | Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure | Through 30 days |
| Major Vascular and Bleeding Complications | Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure | Through 6 Months |
| Other Secondary Safety Events | Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major). | Through 30 days |
| Other Secondary Safety Events | Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major). | Through 6 months |
| Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | Baseline |
| Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | During the hospital stay with a maximum of 3 days post index procedure (Discharge) |
| Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | 12 months |
| Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | 24 months |
| Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | 60 months |
| Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | Baseline |
| Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | During the hospital stay with a maximum of 3 days post index procedure (Discharge) |
| Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | 12 months |
| Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | 24 months |
| Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | 60 months |
| Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | Baseline |
| Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | During the hospital stay with a maximum of 3 days post index procedure (Discharge) |
| Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | 12 months |
| Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | 24 months |
| Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | 60 months |
| Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | Baseline |
| Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | During the hospital stay with a maximum of 3 days post index procedure (Discharge) |
| Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | 12 months |
| Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | 24 months |
| Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | 60 months |
| Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | Baseline |
| Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | During the hospital stay with a maximum of 3 days post index procedure (Discharge) |
| Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | 12 months |
| Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | 24 months |
| Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | 60 months |
| Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | Baseline |
| Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | During the hospital stay with a maximum of 3 days post index procedure (Discharge) |
| Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | 12 months |
| Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | 24 months |
| Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | 60 months |
| Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | Baseline |
| Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | During the hospital stay with a maximum of 3 days post index procedure (Discharge) |
| Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | 12 months |
| Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | 24 months |
| Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | 60 months |
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | Baseline |
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | 6 months |
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | 30 days |
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | 12 months |
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | 18 months |
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | 24 months |
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | 36 months |
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | 48 months |
| New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | 60 months |
| 17080467 | Background | Herrmann HC, Rohatgi S, Wasserman HS, Block P, Gray W, Hamilton A, Zunamon A, Homma S, Di Tullio MR, Kraybill K, Merlino J, Martin R, Rodriguez L, Stewart WJ, Whitlow P, Wiegers SE, Silvestry FE, Foster E, Feldman T. Mitral valve hemodynamic effects of percutaneous edge-to-edge repair with the MitraClip device for mitral regurgitation. Catheter Cardiovasc Interv. 2006 Dec;68(6):821-8. doi: 10.1002/ccd.20917. |
| 17570634 | Background | Silvestry FE, Rodriguez LL, Herrmann HC, Rohatgi S, Weiss SJ, Stewart WJ, Homma S, Goyal N, Pulerwitz T, Zunamon A, Hamilton A, Merlino J, Martin R, Krabill K, Block PC, Whitlow P, Tuzcu EM, Kapadia S, Gray WA, Reisman M, Wasserman H, Schwartz A, Foster E, Feldman T, Wiegers SE. Echocardiographic guidance and assessment of percutaneous repair for mitral regurgitation with the Evalve MitraClip: lessons learned from EVEREST I. J Am Soc Echocardiogr. 2007 Oct;20(10):1131-40. doi: 10.1016/j.echo.2007.02.003. Epub 2007 Jun 13. |
| 18703359 | Background | Luk A, Butany J, Ahn E, Fann JI, St Goar F, Thornton T, McDermott L, Madayag C, Komtebedde J. Mitral repair with the Evalve MitraClip device: histopathologic findings in the porcine model. Cardiovasc Pathol. 2009 Sep-Oct;18(5):279-85. doi: 10.1016/j.carpath.2008.07.001. Epub 2008 Aug 13. |
| 19284064 | Background | Herrmann HC, Kar S, Siegel R, Fail P, Loghin C, Lim S, Hahn R, Rogers JH, Bommer WJ, Wang A, Berke A, Lerakis S, Kramer P, Wong SC, Foster E, Glower D, Feldman T; EVEREST Investigators. Effect of percutaneous mitral repair with the MitraClip device on mitral valve area and gradient. EuroIntervention. 2009 Jan;4(4):437-42. doi: 10.4244/eijv4i4a76. |
| 19682161 | Background | Rogers JH, Yeo KK, Carroll JD, Cleveland J, Reece TB, Gillinov AM, Rodriguez L, Whitlow P, Woo YJ, Herrmann HC, Young JN. Late surgical mitral valve repair after percutaneous repair with the MitraClip system. J Card Surg. 2009 Nov-Dec;24(6):677-81. doi: 10.1111/j.1540-8191.2009.00901.x. Epub 2009 Jul 24. |
| 20103209 | Background | Argenziano M, Skipper E, Heimansohn D, Letsou GV, Woo YJ, Kron I, Alexander J, Cleveland J, Kong B, Davidson M, Vassiliades T, Krieger K, Sako E, Tibi P, Galloway A, Foster E, Feldman T, Glower D; EVEREST Investigators. Surgical revision after percutaneous mitral repair with the MitraClip device. Ann Thorac Surg. 2010 Jan;89(1):72-80; discussion p 80. doi: 10.1016/j.athoracsur.2009.08.063. |
| 20219746 | Background | Franzen O, Baldus S, Rudolph V, Meyer S, Knap M, Koschyk D, Treede H, Barmeyer A, Schofer J, Costard-Jackle A, Schluter M, Reichenspurner H, Meinertz T. Acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical-risk patients: emphasis on adverse valve morphology and severe left ventricular dysfunction. Eur Heart J. 2010 Jun;31(11):1373-81. doi: 10.1093/eurheartj/ehq050. Epub 2010 Mar 10. |
| 20299349 | Background | Tamburino C, Ussia GP, Maisano F, Capodanno D, La Canna G, Scandura S, Colombo A, Giacomini A, Michev I, Mangiafico S, Cammalleri V, Barbanti M, Alfieri O. Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting. Eur Heart J. 2010 Jun;31(11):1382-9. doi: 10.1093/eurheartj/ehq051. Epub 2010 Mar 18. |
| 20336809 | Background | Ussia GP, Barbanti M, Tamburino C. Feasibility of percutaneous transcatheter mitral valve repair with the MitraClip system using conscious sedation. Catheter Cardiovasc Interv. 2010 Jun 1;75(7):1137-40. doi: 10.1002/ccd.22415. |
| 20583881 | Background | Jonsson A, Settergren M. MitraClip catheter-based mitral valve repair system. Expert Rev Med Devices. 2010 Jul;7(4):439-47. doi: 10.1586/erd.10.23. |
| 20598968 | Background | Mauri L, Garg P, Massaro JM, Foster E, Glower D, Mehoudar P, Powell F, Komtebedde J, McDermott E, Feldman T. The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation. Am Heart J. 2010 Jul;160(1):23-9. doi: 10.1016/j.ahj.2010.04.009. |
| 20609795 | Background | Geidel S, Ostermeyer J, Lass M, Schmoeckel M. Complex surgical valve repair after failed percutaneous mitral intervention using the MitraClip device. Ann Thorac Surg. 2010 Jul;90(1):277-9. doi: 10.1016/j.athoracsur.2009.12.048. |
| 20806217 | Background | Kalarus Z, Kukulski T, Lekston A, Streb W, Sikora J, Nadziakiewicz P, Gasior M, Polonski L, Zembala M. [Methodology and safety of transvascular reduction of severe ischaemic mitral insufficiency with MitraClip in high-surgical-risk patients - first three cases in Poland]. Kardiol Pol. 2010 Jun;68(6):729-35. Polish. |
| 20839359 | Background | Lim DS, Kunjummen BJ, Smalling R. Mitral valve repair with the MitraClip device after prior surgical mitral annuloplasty. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):455-9. doi: 10.1002/ccd.22547. |
| 20876188 | Background | Ciobanu A, Bennett S, Azam M, Clark A, Vinereanu D. Incremental value of three-dimensional transoesophageal echocardiography for guiding double percutaneous MitraClip (R) implantation in a 'no option' patient. Eur J Echocardiogr. 2011 Feb;12(2):E11. doi: 10.1093/ejechocard/jeq118. Epub 2010 Sep 27. |
| 20948505 | Background | Tamburino C, Imme S, Barbanti M, Mule M, Pistritto AM, Aruta P, Cammalleri V, Scarabelli M, Mangiafico S, Scandura S, Ussia GP. Reduction of mitral valve regurgitation with Mitraclip(R) percutaneous system. Minerva Cardioangiol. 2010 Oct;58(5):589-98. |
| 21036802 | Background | Borgia F, Di Mario C, Franzen O. Adenosine-induced asystole to facilitate MitraClip placement in a patient with adverse mitral valve morphology. Heart. 2011 May;97(10):864. doi: 10.1136/hrt.2010.208132. Epub 2010 Oct 29. No abstract available. |
| 19679246 | Result | Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D; EVEREST Investigators. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol. 2009 Aug 18;54(8):686-94. doi: 10.1016/j.jacc.2009.03.077. |
| 23633132 | Derived | Foster E, Kwan D, Feldman T, Weissman NJ, Grayburn PA, Schwartz A, Rogers JH, Kar S, Rinaldi MJ, Fail PS, Hermiller J, Whitlow PL, Herrmann HC, Lim DS, Glower DD; EVEREST Investigators. Percutaneous mitral valve repair in the initial EVEREST cohort: evidence of reverse left ventricular remodeling. Circ Cardiovasc Imaging. 2013 Jul;6(4):522-30. doi: 10.1161/CIRCIMAGING.112.000098. Epub 2013 Apr 30. |
| 21492763 | Derived | Siegel RJ, Biner S, Rafique AM, Rinaldi M, Lim S, Fail P, Hermiller J, Smalling R, Whitlow PL, Herrmann HC, Foster E, Feldman T, Glower D, Kar S; EVEREST Investigators. The acute hemodynamic effects of MitraClip therapy. J Am Coll Cardiol. 2011 Apr 19;57(16):1658-65. doi: 10.1016/j.jacc.2010.11.043. |
| 21422390 | Derived | Ladich E, Michaels MB, Jones RM, McDermott E, Coleman L, Komtebedde J, Glower D, Argenziano M, Feldman T, Nakano M, Virmani R; Endovascular Valve Edge-to-Edge Repair Study (EVEREST) Investigators. Pathological healing response of explanted MitraClip devices. Circulation. 2011 Apr 5;123(13):1418-27. doi: 10.1161/CIRCULATIONAHA.110.978130. Epub 2011 Mar 21. |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | Based on the number of patients who have not died or withdrawn, and have reached the scheduled visit window | Posted | Number | Percentage of participants | At discharge or within 30 days of the procedure |
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| Primary | Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | Of total 55 patients population 39 patients were analyzed, as for 1 patient Echocardiogram was not performed and 15 patients were withdrawn or lost to follow-up. | Posted | Number | Percentage of participants | At 12 months |
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| Primary | Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | Of total 55 patients population 28 patients were analysed, as for 1 patient Echocardiogram was not performed and 15 patients were withdrawn or lost to follow-up. | Posted | Number | Percentage of participants | At 24 months |
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| Primary | Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | Of total 55 patients population 23 patients were analysed, as for 5 patients Echocardiogram was not performed and 27 patients were withdrawn or lost to follow-up. | Posted | Number | Percentage of participants | At 3 years |
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| Primary | Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | Of total 55 patients population 19 patients were analysed, as for 4 patients Echocardiogram was not performed and 32 patients were withdrawn or lost to follow-up. | Posted | Number | Percentage of participants | At 4 years |
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| Primary | Mitral Regurgitation Severity | All patients were screened and determined eligible by Investigators who utilized transthoracic echocardiograms (TTE) to determine MR severity grades based on the American Society of Echocardiology recommendations for the determination of native valvular regurgitation. MR severity was assessed by an independent Echocardiography Core Laboratory (ECL). | Of total 55 patients population 15 patients were analysed, as 40 patients were withdrawn or lost to follow-up. | Posted | Number | Percentage of participants | At 5 years |
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| Primary | Major Adverse Events (MAE) | Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia. | Posted | Number | Percentage of participants | Through 30 days |
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| Primary | Major Adverse Events (MAE) | Defined in the Protocol as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed MitraClip device, single leaflet device attachment, stroke and septicemia. | Posted | Number | Percentage of participants | Through 6 Months |
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| Secondary | Procedure Time | Procedure Time, defined as the time of start of the transseptal procedure to the time the Steerable Guide Catheter (SOC) is removed, averaged 255 minutes, or just over 4 hours. The reported Procedure Time includes the time required to collect Protocol required hemodynamic data pre- and post-implantation of the MitraClip device. | Posted | Mean | Standard Deviation | Minutes | At day 0 (on the day of index procedure) |
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| Secondary | Device Time | Device Time, defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip Delivery Catheter is retracted into the SGC. | Posted | Mean | Standard Deviation | Minutes | At day 0 (on the day of index procedure) |
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| Secondary | Contrast Volume | Mean contrast volume utilized during the MitraClip procedure. | Contrast volume was not recorded in one patient. Therefore, contrast volume data is available for 54 of the 55 patients. | Posted | Mean | Standard Deviation | Milliliters | At day 0 (on the day of index procedure) |
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| Secondary | Fluoroscopy Duration | Mean fluoroscopy duration during the MitraClip procedure. | Mean fluoroscopy duration was not recorded in one patient. Therefore, mean fluoroscopy data is available for 54 of the 55 patients. | Posted | Mean | Standard Deviation | Minutes | At day 0 (on the day of index procedure) |
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| Secondary | Number of Mitraclip Devices Implanted | Posted | Number | Percentage of participants | At day 0 (on the day of index procedure) |
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| Secondary | Intra-procedural Major Adverse Events | Significant intra-procedural Major adverse events are defined as Major Adverse Events that occurred on the day of the procedure | Posted | Number | percentage of participants | At day 0 (on the day of index procedure) |
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| Secondary | Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration | Posted | Mean | Standard Deviation | Hours | Post index procedure within 30 days |
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| Secondary | Post-procedure Hospital Stay | Posted | Mean | Standard Deviation | Days | Post-index procedure until hospital discharge (1 to 19 days) |
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| Secondary | Second Intervention to Place a Second MitraClip Device | Posted | Number | Participants | Post index procedure through 5 years |
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| Secondary | MitraClip Device Embolizations and Single Leaflet Device Attachment | MitraClip device embolizations means the detachment from both mitral leaflets. Single Leaflet Device Attachment (SLDA) is defined as the attachment of a single leaflet to the MitraClip device. | Of the 55 patients enrolled in the EVEREST I study, 6 patients did not have a MitraClip device implanted. | Posted | Number | Participants | Post index procedure through 5 years |
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| Secondary | Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | Posted | Number | Percentage of participants | At baseline |
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| Secondary | Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 12 months |
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| Secondary | Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 24 months |
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| Secondary | Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 3 Years |
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| Secondary | Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 4 Years |
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| Secondary | Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery) | Freedom from mitral valve surgery required to treat mitral regurgitation and/or mitral stenosis and/or for Cardiac Surgery for Failed Clip following the MitraClip device procedure. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 5 Years |
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| Secondary | Death (Kaplan-Meier Freedom From Death) | Posted | Number | Percentage of participants | Within 30 days of the procedure |
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| Secondary | Death (Kaplan-Meier Freedom From Death) | Posted | Number | 95% Confidence Interval | Percentage of participants | At 12 months |
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| Secondary | Death (Kaplan-Meier Freedom From Death) | Posted | Number | 95% Confidence Interval | Percentage of participants | At 24 months |
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| Secondary | Death (Kaplan-Meier Freedom From Death) | Posted | Number | 95% Confidence Interval | Percentage of participants | At 3 years |
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| Secondary | Death (Kaplan-Meier Freedom From Death) | Posted | Number | 95% Confidence Interval | Percentage of participants | At 4 years |
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| Secondary | Death (Kaplan-Meier Freedom From Death) | Posted | Number | 95% Confidence Interval | Percentage of participants | At 5 years |
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| Secondary | Major Vascular and Bleeding Complications | Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure | Posted | Number | percentage of participants | Through 30 days |
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| Secondary | Major Vascular and Bleeding Complications | Major bleeding complications is defined as transfusion of >=2 units of blood due to bleeding related to the index procedure | Posted | Number | percentage of participants | Through 6 Months |
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| Secondary | Other Secondary Safety Events | Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major). | Posted | Number | percentage of participants | Through 30 days |
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| Secondary | Other Secondary Safety Events | Other safety event includes Endocarditis, MitraClip DeviceThrombosis, Hemolysis, Mitral Valve Injury (major). | Posted | Number | percentage of participants | Through 6 months |
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| Secondary | Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | Milliliter | Baseline |
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| Secondary | Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | Milliliter | During the hospital stay with a maximum of 3 days post index procedure (Discharge) |
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| Secondary | Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | Milliliter | 12 months |
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| Secondary | Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | Milliliter | 24 months |
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| Secondary | Left Ventricular End Diastolic Volume | Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | Milliliter | 60 months |
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| Secondary | Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | Milliliter | Baseline |
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| Secondary | Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | Milliliter | During the hospital stay with a maximum of 3 days post index procedure (Discharge) |
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| Secondary | Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | Milliliter | 12 months |
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| Secondary | Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | Milliliter | 24 months |
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| Secondary | Left Ventricular End Systolic Volume | Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | Milliliter | 60 months |
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| Secondary | Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | cm^2 | Baseline |
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| Secondary | Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | cm^2 | During the hospital stay with a maximum of 3 days post index procedure (Discharge) |
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| Secondary | Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | cm^2 | 12 months |
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| Secondary | Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | cm^2 | 24 months |
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| Secondary | Mitral Valve Area - Single Orifice | Mitral valve area measured by planimetry. Using a cineloop acquired at the mitral valve leaflet tips, the point in diastole corresponding to the maximal opening is identified. The area pre-device as well as post-device are planimetered. Post-device, the mitral valve orifice area is the sum of the area of each of the two orifices. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | cm^2 | 60 months |
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| Secondary | Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | cm^2 | Baseline |
|
|
|
| Secondary | Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | cm^2 | During the hospital stay with a maximum of 3 days post index procedure (Discharge) |
|
|
|
| Secondary | Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | cm^2 | 12 months |
|
|
|
| Secondary | Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | cm^2 | 24 months |
|
|
|
| Secondary | Mitral Valve Area (MVA) by Pressure Half-Time | The pressure half time (PHT) measurement for assessing the severity of mitral stenosis is a widely accepted echocardiographic method. The decline of the velocity of diastolic transmitral blood flow is inversely proportional to mitral valve area (MVA), and MVA is derived using the empirical formula: MVA (cm^2) = 220/PHT PHT is calculated automatically by tracing the deceleration slope of the E-wave of transmitral flow, obtained with continuous wave Doppler echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | cm^2 | 60 months |
|
|
|
| Secondary | Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline |
|
|
|
| Secondary | Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | mmHg | During the hospital stay with a maximum of 3 days post index procedure (Discharge) |
|
|
|
| Secondary | Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | mmHg | 12 months |
|
|
|
| Secondary | Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | mmHg | 24 months |
|
|
|
| Secondary | Mitral Valve Gradient | Defined as the mean and peak pressure gradients across the mitral valve as measured by echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | mmHg | 60 months |
|
|
|
| Secondary | Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | L/min | Baseline |
|
|
|
| Secondary | Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | L/min | During the hospital stay with a maximum of 3 days post index procedure (Discharge) |
|
|
|
| Secondary | Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | L/min | 12 months |
|
|
|
| Secondary | Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | L/min | 24 months |
|
|
|
| Secondary | Cardiac Output | Cardiac output as measured by core lab echocardiography. Cardiac output is the product of forward stroke volume and heart rate. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | L/min | 60 months |
|
|
|
| Secondary | Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | L/min/m^2 | Baseline |
|
|
|
| Secondary | Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | L/min/m^2 | During the hospital stay with a maximum of 3 days post index procedure (Discharge) |
|
|
|
| Secondary | Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | L/min/m^2 | 12 months |
|
|
|
| Secondary | Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | L/min/m^2 | 24 months |
|
|
|
| Secondary | Cardiac Index | Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index is measured by core lab echocardiography. | Some patients are not analyzed due to non-evaluable echocardiograms or echocardiograms not done. | Posted | Mean | 95% Confidence Interval | L/min/m^2 | 60 months |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | Posted | Number | participants | Baseline |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | NYHA functional class was evaluated in 41 patients at the 6-month follow-up visit. NYHA assessment is missing in 14 patients due to:
| Posted | Number | participants | 6 months |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | NYHA functional class was evaluated in 47 patients at the 30-day follow-up visit. NYHA assessment is missing in 8 patients due to:
| Posted | Number | participants | 30 days |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | NYHA functional class was evaluated in 39 patients at the 12-month follow-up visit. NYHA assessment is missing in 16 patients due to:
| Posted | Number | participants | 12 months |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | NYHA functional class was evaluated in 27 patients at the 18-month follow-up visit. NYHA assessment is missing in 28 patients due to:
| Posted | Number | participants | 18 months |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | NYHA functional class was evaluated in 28 patients at the 24-month follow-up visit. NYHA assessment is missing in 27 patients due to:
| Posted | Number | participants | 24 months |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | NYHA functional class was evaluated in 21 patients at the 36-month follow-up visit. NYHA assessment is missing in 34 patients due to:
| Posted | Number | participants | 36 months |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | NYHA functional class was evaluated in 19 patients at the 48-month follow-up visit. NYHA assessment is missing in 36 patients due to:
| Posted | Number | participants | 48 months |
|
|
|
| Secondary | New York Heart Association (NYHA) Functional Class | Defined as assessment of NYHA functional class status at follow-up compared to baseline NYHA functional class status. 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. | NYHA functional class was evaluated in 15 patients at the 48-month follow-up visit. NYHA assessment is missing in 40 patients due to:
| Posted | Number | participants | 60 months |
|
|
|
| 36 |
| 55 |
| 43 |
| 55 |
| Anaemia haemolytic autoimmune | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Right ventricular failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mechanical complication of implant | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Catheter sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Device malfunction | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Bleeding time prolonged | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Neurological symptom | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary haematoma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arteriovenous fistula operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Blood product transfusion | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Coronary revascularisation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Hernia repair | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Hip surgery | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Implantable defibrillator insertion | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
|
| Arteriovenous fistula | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mitral valve stenosis | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bleeding time prolonged | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dyspnoea exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Not provided
| D003327 |
| Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| Title | Measurements |
|---|---|
|
| 3+:Moderate-to-Severe |
|
| 4+:Severe |
|
| Title | Measurements |
|---|---|
|
| 3+:Moderate-to-Severe |
|
| 4+:Severe |
|
| Title | Measurements |
|---|---|
|
| 3+:Moderate-to-Severe |
|
| 4+:Severe |
|
| Title | Measurements |
|---|---|
|
| 3+:Moderate-to-Severe |
|
| 4+:Severe |
|
| Title | Measurements |
|---|---|
|
| 3+:Moderate-to-Severe |
|
| 4+:Severe |
|
| Title | Measurements |
|---|---|
|
| 3+:Moderate-to-Severe |
|
| 4+:Severe |
|
| Title | Measurements |
|---|---|
|
| Cardiac Surgery for failed MitraClip Device |
|
| Single Leaflet Device Attachment (SLDA) |
|
| Stroke |
|
| Septicemia |
|
| Title | Measurements |
|---|---|
|
| Cardiac Surgery for failed MitraClip Device |
|
| Single Leaflet Device Attachment (SLDA) |
|
| Stroke |
|
| Septicemia |
|
| Title | Measurements |
|---|
|
| Cardiac Surgery for failed MitraClip Device |
|
| Single Leaflet Device Attachment (SLDA) |
|
| Stroke |
|
| Septicemia |
|
| Title |
|---|
| Measurements |
|---|
|
| Title |
|---|
| Measurements |
|---|
|
| Measurements |
|---|
|
| Mitral Valve Injury (major) |
|
| Measurements |
|---|
|
| Mitral Valve Injury (major) |
|
| Title | Measurements |
|---|---|
|
| NYHA Functional Class IV |
|
| Title | Measurements |
|---|---|
|
| NYHA Functional Class IV |
|
| Title | Measurements |
|---|---|
|
| NYHA Functional Class IV |
|
| Title | Measurements |
|---|---|
|
| NYHA Functional Class IV |
|
| Title | Measurements |
|---|---|
|
| NYHA Functional Class IV |
|
| Title | Measurements |
|---|---|
|
| NYHA Functional Class IV |
|
| Title | Measurements |
|---|---|
|
| NYHA Functional Class IV |
|
| Title | Measurements |
|---|---|
|
| NYHA Functional Class IV |
|
| Title | Measurements |
|---|---|
|
| NYHA Functional Class IV |
|