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The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure
There is limited local evidence on mitral repair products in South Asia and a prospective post market registry will provide real world data on clinical outcomes.
Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings will be considered for study participation.
PRESERVE-Mitral Registry is a prospective non-randomized, non-interventional, post-market registry
The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trail was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Heath Service Act or 42 CRF 11.24 and 11.44.)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Profile 3D™ and CG Future® annuloplasty system | Device | Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Mitral Regurgitation (MR) Grade at 12-months Post Procedure | This is determined by assessing the level of mitral valve regurgitation using echo, in subjects at 12-months post-procedure compared to the level at baseline. The levels of regurgitation, level 0-4, correspond to the American Society of Echocardiography (ASE) guidelines ranging from no MR, Mild MR, Moderate MR, Moderate- to-Severe MR and Severe MR. A percentage number is calculated to reflect how many participants had an MR improvement. | 12 months |
| All Cause Mortality | All deaths occurring from any cause 12-months post procedure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Improvement in MR Grade at Discharge and First Follow-up (3-6 Months) | This was determined by assessing the level of mitral valve regurgitation using hemodynamic performance, in subjects at discharge and 3-6 months post-procedure compared to the level at baseline. The levels of regurgitation, level 0-4, correspond to the ASE guidelines ranging from no MR, Mild MR, Moderate MR, Moderate-to-Severe MR and Severe MR |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications as per instructions-for-use (IFU):
Aortic valve replacement as concomitant procedure
Already participating in another clinical study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints
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Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings
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| Name | Affiliation | Role |
|---|---|---|
| Vinay Rajan, Ph.D | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Heart Foundation Hospital & Research Institute | Dhaka | 1216 | Bangladesh | |||
| U. N. Mehta Institute of Cardiology and Research Centre |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
200 total subjects enrolled, 184 had an attempted; and, 180 were successfully implanted and followed. Data reported is for the Successfully Implanted (IMP) cohort n=180.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data reported is for the Successfully Implanted (IMP) cohort n=180. |
| 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 | Improvement in Mitral Regurgitation (MR) Grade at 12-months Post Procedure | This is determined by assessing the level of mitral valve regurgitation using echo, in subjects at 12-months post-procedure compared to the level at baseline. The levels of regurgitation, level 0-4, correspond to the American Society of Echocardiography (ASE) guidelines ranging from no MR, Mild MR, Moderate MR, Moderate- to-Severe MR and Severe MR. A percentage number is calculated to reflect how many participants had an MR improvement. | Data reported is for the Successfully Implanted (IMP) cohort n=180. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
1 year
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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 | Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jenell Lorenz, Sr. Clinical Research Specialist | Medtronic | 651-269-4768 | jenell.m.lorenz@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2017 | Jun 13, 2022 | Prot_SAP_000.pdf |
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| At discharge from hospital (up to 7 days) and at first follow-up (3-6month) |
| Improvement in NYHA Functional Class at Discharge, First Follow-up (3-6 Months) and Second Follow-up (12-months) Compared to Baseline. | The percentage of subjects with an improved New York Heart Association NYHA functional class using a two-sided 95% exact binomial confidence internal measured at discharge, 3-6 months, and 12-months post-procedure and compared to baseline. | At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months) |
| Hospitalization for Heart Failure at 6 Months and at 12 Months Post Procedure | Subjects who have a non-elective hospital admission for signs and symptoms related to heart failure that results in a one night stay (i.e., where the admission date and the discharge date differ by at least one calendar day) | 6 months and 12 months post procedure |
| Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure | Subject leaving the operating theater with an implanted Profile 3DTM or CG Future® annuloplasty system and later undergo any surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces the previously implanted annuloplasty system is considered a reoperation | At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months) |
| Stroke at 6 Months and at 12 Months Post Procedure | Subjects had an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction, where the neurological dysfunction lasts for greater than 24-hours | 6 months and 12 months post procedure |
| New Onset of Atrial Fibrillation, as Evaluated Through Follow up ECG at Discharge, First Follow up (3-6months) and at Second Follow up (12 Months) | New onset of AF is defined as when the subject did not present with prior history of AF at baseline nor was AF detected at baseline visit, but AF did manifest post procedure and was either diagnosed during the study visits (discharge, 3-6 months or 12 months visit) or was otherwise diagnosed during the duration of subject participation in the study. The incidence of new onset AF will be evaluated at discharge, first follow up (3-6 months) and at second follow up (12 months). This endpoint is analyzed for the Successfully Implanted (IMP) cohort and provided as a Kaplan-Meier analysis. | At discharge from hospital, (up to 7 days), at first follow-up (3-6month), and at the second follow-up (12 months) |
| Number of Attempts Required for Procedural Success | Number of surgical attempts required for procedural implant success | Procedure (defined as the date of the first attempted procedure through subject leaving the operating theater with an implanted Profile 3D or CG Future annuloplasty system) |
| Total Bypass Time During the Implant Procedure | Total time a subject is on bypass time as a measure of procedural complexity | During the procedure as measured by standard operating procedures at the sites |
| Ahmedabad |
| Gujarat |
| 380016 |
| India |
| SAL Hospital & Medical Institute | Ahmedabad | Gujarat | 380054 | India |
| EPIC Hospital | Ahmedabad | Gujarat | 380060 | India |
| Sri Jayadeva Institute of Cardiovascular Sciences & Research | Bangalore | Karnataka | 560069 | India |
| Narayana Institute of Cardiac Sciences | Bangalore | Karnataka | 560099 | India |
| Amrita Institute of Medical Sciences and Research Center | Kochi | Kerala | 682041 | India |
| P.D. Hinduja National Hospital and Medical Research Centre | Mumbai | Maharashtra | 400016 | India |
| The Madras Medical Mission | Chennai | Tamil Nadu | 600037 | India |
| G. Kuppuswamy Memorial Hospital | Coimbatore | Tamil Nadu | 641037 | India |
| CARE Hospitals | Hyderabad | Telangana | 500034 | India |
| Manmohan Cardiothoracic Vascular and Transplant Center | Kathmandu | Nepal |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Data reported is for the Successfully Implanted (IMP) cohort n=180. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Data reported is for the Successfully Implanted (IMP) cohort n=180. | Number | participants |
|
| Weight | Demographics and baseline characteristics are summarized for the Enrolled and Successfully Implanted analysis sets including subject weight. | Data reported is for the Successfully Implanted (IMP) cohort n=180. | Mean | Standard Deviation | kg |
|
| Height | Demographics and baseline characteristics including height are summarized for the Enrolled and Successfully Implanted analysis sets | Data reported is for the Successfully Implanted (IMP) cohort n=180. | Mean | Standard Deviation | cm |
|
| NYHA Classification | The New York Heart Association (NYHA) Functional Classification is a system for defining cardiac disease and related functional limitations into four broad categorizations: NYHA Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. | Data reported is for the Successfully Implanted (IMP) cohort n=180, there are 8 subjects that did not have a reported NYHA classification. | Count of Participants | Participants |
|
| Cardiac Rhythm | Data reported is for the Successfully Implanted (IMP) cohort n=180. Two subjects did not have an ECG reported at baseline. | Count of Participants | Participants |
|
| Surgical History | Data reported is for the Successfully Implanted (IMP) cohort n=180. | Count of Participants | Participants |
|
| Risk Factors | Data reported is for the Successfully Implanted (IMP) cohort n=180. | Count of Participants | Participants |
|
| Mitral Valve Pathophysiology | Data reported is for the Successfully Implanted (IMP) cohort n=180. | Count of Participants | Participants |
|
| Mitral Valve Regurgitation | Data reported is for the Successfully Implanted (IMP) cohort n=180. | Count of Participants | Participants |
|
|
|
| Primary | All Cause Mortality | All deaths occurring from any cause 12-months post procedure | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Percentage of Participants With Improvement in MR Grade at Discharge and First Follow-up (3-6 Months) | This was determined by assessing the level of mitral valve regurgitation using hemodynamic performance, in subjects at discharge and 3-6 months post-procedure compared to the level at baseline. The levels of regurgitation, level 0-4, correspond to the ASE guidelines ranging from no MR, Mild MR, Moderate MR, Moderate-to-Severe MR and Severe MR | Of the 180 implanted subjects, 161 returned for the first follow-up visit at 3-6 months and had an echo performed, primarily due to standard of care practices at participating facilities. | Posted | Number | 95% Confidence Interval | percentage of patients with improved MR | At discharge from hospital (up to 7 days) and at first follow-up (3-6month) |
|
|
|
| Secondary | Improvement in NYHA Functional Class at Discharge, First Follow-up (3-6 Months) and Second Follow-up (12-months) Compared to Baseline. | The percentage of subjects with an improved New York Heart Association NYHA functional class using a two-sided 95% exact binomial confidence internal measured at discharge, 3-6 months, and 12-months post-procedure and compared to baseline. | Subject follow-up based on standard of care at participating centers | Posted | Number | 95% Confidence Interval | percentage of participants | At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months) |
|
|
|
| Secondary | Hospitalization for Heart Failure at 6 Months and at 12 Months Post Procedure | Subjects who have a non-elective hospital admission for signs and symptoms related to heart failure that results in a one night stay (i.e., where the admission date and the discharge date differ by at least one calendar day) | Data reported is for the Successfully Implanted (IMP) cohort n=180. Data was not reported for 19 subjects at the 6 month visit and 70 subjects at the 12 month visit. | Posted | Count of Participants | Participants | 6 months and 12 months post procedure |
|
|
|
| Secondary | Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure | Subject leaving the operating theater with an implanted Profile 3DTM or CG Future® annuloplasty system and later undergo any surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces the previously implanted annuloplasty system is considered a reoperation | Data reported is for the Successfully Implanted (IMP) cohort n=180. | Posted | Count of Participants | Participants | At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months) |
|
|
|
| Secondary | Stroke at 6 Months and at 12 Months Post Procedure | Subjects had an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction, where the neurological dysfunction lasts for greater than 24-hours | Data reported is for the Successfully Implanted (IMP) cohort n=180. Data was not reported for 17 subjects at 6 months and 68 subjects at 12 months. | Posted | Count of Participants | Participants | 6 months and 12 months post procedure |
|
|
|
| Secondary | New Onset of Atrial Fibrillation, as Evaluated Through Follow up ECG at Discharge, First Follow up (3-6months) and at Second Follow up (12 Months) | New onset of AF is defined as when the subject did not present with prior history of AF at baseline nor was AF detected at baseline visit, but AF did manifest post procedure and was either diagnosed during the study visits (discharge, 3-6 months or 12 months visit) or was otherwise diagnosed during the duration of subject participation in the study. The incidence of new onset AF will be evaluated at discharge, first follow up (3-6 months) and at second follow up (12 months). This endpoint is analyzed for the Successfully Implanted (IMP) cohort and provided as a Kaplan-Meier analysis. | Data reported is for the Successfully Implanted (IMP) | Posted | Number | 95% Confidence Interval | percentage of participants | At discharge from hospital, (up to 7 days), at first follow-up (3-6month), and at the second follow-up (12 months) |
|
|
|
| Secondary | Number of Attempts Required for Procedural Success | Number of surgical attempts required for procedural implant success | Data reported is for the Successfully Implanted (IMP) cohort n=180. | Posted | Count of Participants | Participants | Procedure (defined as the date of the first attempted procedure through subject leaving the operating theater with an implanted Profile 3D or CG Future annuloplasty system) |
|
|
|
| Secondary | Total Bypass Time During the Implant Procedure | Total time a subject is on bypass time as a measure of procedural complexity | Data reported is for the Successfully Implanted (IMP) cohort n=180. | Posted | Mean | Standard Deviation | Minutes | During the procedure as measured by standard operating procedures at the sites |
|
|
|
| 6 |
| 180 |
| 24 |
| 180 |
| 0 |
| 180 |
| Atrial Fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cardiopulmonary Failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Left Ventricular Dysfunction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Right Ventricular Dysfunction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 24.0 | Systematic Assessment | Unknown cause |
|
| Pyelonephritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Renal Transplant | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
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|
|
| 12 Months |
|
|
|
| Title | Measurements |
|---|---|
|
|
|
| 12 months |
|
|