Mitral Valve Disease
Conditions
Brief summary
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
Detailed description
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.)
Interventions
DEVICEProfile 3D™ and CG Future® annuloplasty system
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
Sponsors
Medtronic Cardiac Surgery
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with valvular insufficiency and/or stenosis and indicated for the reconstruction and/or remodeling of pathological mitral valves with Profile 3D™ and CG Future® annuloplasty systems 2. Indications and contraindications provided in the product Instructions for Use 3. Subject is 18 years of age or older 4. The patient or his/her Legally Authorized Representative (LAR) has been informed about the nature of the registry and the patient informed consent for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements
Exclusion criteria
1. Contraindications as per instructions-for-use (IFU): 1. Heavily calcified valves 2. Valvular retraction with severely reduced mobility 3. Active bacterial endocarditis 2. Aortic valve replacement as concomitant procedure 3. Already participating in another clinical study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Mitral Regurgitation (MR) Grade at 12-months Post Procedure | 12 months | 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. |
| All Cause Mortality | 12 months | All deaths occurring from any cause 12-months post procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization for Heart Failure at 6 Months and at 12 Months Post Procedure | 6 months and 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) |
| Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure | At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months) | 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 |
| Stroke at 6 Months and at 12 Months Post Procedure | 6 months and 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 |
| Percentage of Participants With Improvement in MR Grade at Discharge and First Follow-up (3-6 Months) | At discharge from hospital (up to 7 days) and at first follow-up (3-6month) | 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 |
| Number of Attempts Required for Procedural 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) | Number of surgical attempts required for procedural implant success |
| Total Bypass Time During the Implant Procedure | During the procedure as measured by standard operating procedures at the sites | Total time a subject is on bypass time as a measure of procedural complexity |
| 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) | At discharge from hospital, (up to 7 days), at first follow-up (3-6month), and at the 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. |
| Improvement in NYHA Functional Class at Discharge, First Follow-up (3-6 Months) and Second Follow-up (12-months) 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) | 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. |
Countries
Bangladesh, India, Nepal
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 180 |
| Total | 180 |
Baseline characteristics
| Characteristic | Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | — |
|---|---|---|
| Age, Continuous | 50.4 years STANDARD_DEVIATION 15 | — |
| Cardiac Rhythm Atrial Fibrillation | 10 Participants | — |
| Cardiac Rhythm Atrial Flutter | 2 Participants | — |
| Cardiac Rhythm Normal Sinus Rhythm | 154 Participants | — |
| Cardiac Rhythm Other | 12 Participants | — |
| Height | 161.4 cm STANDARD_DEVIATION 9.5 | — |
| Mitral Valve Pathophysiology Barlow's Disease | 7 Participants | — |
| Mitral Valve Pathophysiology Congenital Pathophysiology | 2 Participants | — |
| Mitral Valve Pathophysiology Ischemic Pathophysiology | 76 Participants | — |
| Mitral Valve Pathophysiology Marfan's Syndrome | 1 Participants | — |
| Mitral Valve Pathophysiology Myxomatous | 23 Participants | — |
| Mitral Valve Pathophysiology Rheumatic Pathophysiology | 72 Participants | — |
| Mitral Valve Regurgitation Moderate | 29 Participants | — |
| Mitral Valve Regurgitation Moderate to Severe | 14 Participants | — |
| Mitral Valve Regurgitation Severe | 137 Participants | — |
| NYHA Classification Class I | 6 Participants | — |
| NYHA Classification Class II | 91 Participants | — |
| NYHA Classification Class III | 66 Participants | — |
| NYHA Classification Class IV | 9 Participants | — |
| NYHA Classification No Heart Failure | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Bangladesh | 23 participants | — |
| Region of Enrollment India | 144 participants | — |
| Region of Enrollment Nepal | 13 participants | — |
| Risk Factors Atrial Fibrillation | 1 Participants | — |
| Risk Factors Congestive Heart Failure | 21 Participants | — |
| Risk Factors Coronary Artery Disease | 87 Participants | — |
| Risk Factors Diabetes Mellitus | 60 Participants | — |
| Risk Factors Other | 34 Participants | — |
| Risk Factors Pulmonary Hypertension | 9 Participants | — |
| Risk Factors Renal Insufficiency, Dialysis | 2 Participants | — |
| Risk Factors Systemic Hypertension | 54 Participants | — |
| Sex: Female, Male Female | 65 Participants | — |
| Sex: Female, Male Male | 115 Participants | — |
| Surgical History Coronary artery bypass graft (CABG) | 1 Participants | — |
| Surgical History Other | 9 Participants | — |
| Surgical History Percutaneous transluminal coronary angioplasty (PTCA) | 5 Participants | — |
| Weight | 61.4 kg STANDARD_DEVIATION 12.2 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 180 |
| other Total, other adverse events | 0 / 180 |
| serious Total, serious adverse events | 24 / 180 |
Outcome results
Primary
All Cause Mortality
All deaths occurring from any cause 12-months post procedure
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | All Cause Mortality | 6 participants |
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.
Time frame: 12 months
Population: Data reported is for the Successfully Implanted (IMP) cohort n=180.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Improvement in Mitral Regurgitation (MR) Grade at 12-months Post Procedure | 97.8 percentage of participants |
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)
Time frame: 6 months and 12 months post procedure
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Hospitalization for Heart Failure at 6 Months and at 12 Months Post Procedure | 6 Months | 4 Participants |
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Hospitalization for Heart Failure at 6 Months and at 12 Months Post Procedure | 12 Months | 1 Participants |
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.
Time frame: At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months)
Population: Subject follow-up based on standard of care at participating centers
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Improvement in NYHA Functional Class at Discharge, First Follow-up (3-6 Months) and Second Follow-up (12-months) Compared to Baseline. | Discharge | 73.4 percentage of participants |
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Improvement in NYHA Functional Class at Discharge, First Follow-up (3-6 Months) and Second Follow-up (12-months) Compared to Baseline. | 3-6 Months | 84.5 percentage of participants |
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Improvement in NYHA Functional Class at Discharge, First Follow-up (3-6 Months) and Second Follow-up (12-months) Compared to Baseline. | 12 Months | 83.8 percentage of participants |
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
Time frame: At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months)
Population: Data reported is for the Successfully Implanted (IMP) cohort n=180.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure | 12 months | 0 Participants |
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure | Discharge | 0 Participants |
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure | Discharge through 6 months | 0 Participants |
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.
Time frame: At discharge from hospital, (up to 7 days), at first follow-up (3-6month), and at the second follow-up (12 months)
Population: Data reported is for the Successfully Implanted (IMP)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | 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) | Discharge | 3.6 percentage of participants |
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | 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) | 3-6 Months | 4.8 percentage of participants |
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | 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) | 12 months | 4.8 percentage of participants |
Secondary
Number of Attempts Required for Procedural Success
Number of surgical attempts required for procedural implant success
Time frame: 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)
Population: Data reported is for the Successfully Implanted (IMP) cohort n=180.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Number of Attempts Required for Procedural Success | One Attempt | 177 Participants |
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Number of Attempts Required for Procedural Success | Two Attempts | 3 Participants |
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
Time frame: At discharge from hospital (up to 7 days) and at first follow-up (3-6month)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Percentage of Participants With Improvement in MR Grade at Discharge and First Follow-up (3-6 Months) | Discharge | 100 percentage of patients with improved MR |
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Percentage of Participants With Improvement in MR Grade at Discharge and First Follow-up (3-6 Months) | 3-6 month | 97.5 percentage of patients with improved MR |
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
Time frame: 6 months and 12 months post procedure
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Stroke at 6 Months and at 12 Months Post Procedure | 6 month | 2 Participants |
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Stroke at 6 Months and at 12 Months Post Procedure | 12 month | 0 Participants |
Secondary
Total Bypass Time During the Implant Procedure
Total time a subject is on bypass time as a measure of procedural complexity
Time frame: During the procedure as measured by standard operating procedures at the sites
Population: Data reported is for the Successfully Implanted (IMP) cohort n=180.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System | Total Bypass Time During the Implant Procedure | 125.1 Minutes | Standard Deviation 47 |