Trial Outcomes & Findings for PRESERVE-MITRAL Post-Market Registry (NCT NCT03283722)
NCT ID: NCT03283722
Last Updated: 2025-02-11
Results Overview
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.
COMPLETED
200 participants
12 months
2025-02-11
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
COMPLETED
|
180
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data reported is for the Successfully Implanted (IMP) cohort n=180.
Baseline characteristics by cohort
| Measure |
Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System
n=180 Participants
Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device.
|
|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 15.0 • n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Sex: Female, Male
Female
|
65 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Sex: Female, Male
Male
|
115 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Region of Enrollment
Bangladesh
|
23 participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Region of Enrollment
Nepal
|
13 participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Region of Enrollment
India
|
144 participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Weight
|
61.4 kg
STANDARD_DEVIATION 12.2 • n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Height
|
161.4 cm
STANDARD_DEVIATION 9.5 • n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
NYHA Classification
No Heart Failure
|
0 Participants
n=172 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180, there are 8 subjects that did not have a reported NYHA classification.
|
|
NYHA Classification
Class I
|
6 Participants
n=172 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180, there are 8 subjects that did not have a reported NYHA classification.
|
|
NYHA Classification
Class II
|
91 Participants
n=172 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180, there are 8 subjects that did not have a reported NYHA classification.
|
|
NYHA Classification
Class III
|
66 Participants
n=172 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180, there are 8 subjects that did not have a reported NYHA classification.
|
|
NYHA Classification
Class IV
|
9 Participants
n=172 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180, there are 8 subjects that did not have a reported NYHA classification.
|
|
Cardiac Rhythm
Atrial Fibrillation
|
10 Participants
n=178 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180. Two subjects did not have an ECG reported at baseline.
|
|
Cardiac Rhythm
Atrial Flutter
|
2 Participants
n=178 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180. Two subjects did not have an ECG reported at baseline.
|
|
Cardiac Rhythm
Normal Sinus Rhythm
|
154 Participants
n=178 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180. Two subjects did not have an ECG reported at baseline.
|
|
Cardiac Rhythm
Other
|
12 Participants
n=178 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180. Two subjects did not have an ECG reported at baseline.
|
|
Surgical History
Coronary artery bypass graft (CABG)
|
1 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
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|
Surgical History
Percutaneous transluminal coronary angioplasty (PTCA)
|
5 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Surgical History
Other
|
9 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Risk Factors
Atrial Fibrillation
|
1 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Risk Factors
Congestive Heart Failure
|
21 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Risk Factors
Coronary Artery Disease
|
87 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Risk Factors
Diabetes Mellitus
|
60 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Risk Factors
Pulmonary Hypertension
|
9 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Risk Factors
Renal Insufficiency, Dialysis
|
2 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Risk Factors
Systemic Hypertension
|
54 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Risk Factors
Other
|
34 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Mitral Valve Pathophysiology
Barlow's Disease
|
7 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Mitral Valve Pathophysiology
Congenital Pathophysiology
|
2 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Mitral Valve Pathophysiology
Ischemic Pathophysiology
|
76 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Mitral Valve Pathophysiology
Marfan's Syndrome
|
1 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Mitral Valve Pathophysiology
Rheumatic Pathophysiology
|
72 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Mitral Valve Pathophysiology
Myxomatous
|
23 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Mitral Valve Regurgitation
Moderate
|
29 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Mitral Valve Regurgitation
Moderate to Severe
|
14 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
|
Mitral Valve Regurgitation
Severe
|
137 Participants
n=180 Participants • Data reported is for the Successfully Implanted (IMP) cohort n=180.
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data reported is for the Successfully Implanted (IMP) cohort n=180.
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.
Outcome measures
| Measure |
Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System
n=180 Participants
Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device.
|
|---|---|
|
Improvement in Mitral Regurgitation (MR) Grade at 12-months Post Procedure
|
97.8 percentage of participants
Interval 93.8 to 99.6
|
PRIMARY outcome
Timeframe: 12 monthsAll deaths occurring from any cause 12-months post procedure
Outcome measures
| Measure |
Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System
n=180 Participants
Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device.
|
|---|---|
|
All Cause Mortality
|
6 participants
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System
n=180 Participants
Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device.
|
|---|---|
|
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
Interval 98.0 to 100.0
|
|
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
Interval 93.8 to 99.3
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System
n=180 Participants
Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device.
|
|---|---|
|
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
Interval 66.0 to 79.9
|
|
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
Interval 77.8 to 89.8
|
|
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
Interval 76.7 to 89.5
|
SECONDARY outcome
Timeframe: 6 months and 12 months post procedurePopulation: 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.
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)
Outcome measures
| Measure |
Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System
n=180 Participants
Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device.
|
|---|---|
|
Hospitalization for Heart Failure at 6 Months and at 12 Months Post Procedure
6 Months
|
4 Participants
|
|
Hospitalization for Heart Failure at 6 Months and at 12 Months Post Procedure
12 Months
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System
n=180 Participants
Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device.
|
|---|---|
|
Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure
Discharge
|
0 Participants
|
|
Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure
Discharge through 6 months
|
0 Participants
|
|
Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure
12 months
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months and 12 months post procedurePopulation: 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.
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
Outcome measures
| Measure |
Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System
n=180 Participants
Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device.
|
|---|---|
|
Stroke at 6 Months and at 12 Months Post Procedure
6 month
|
2 Participants
|
|
Stroke at 6 Months and at 12 Months Post Procedure
12 month
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System
n=169 Participants
Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device.
|
|---|---|
|
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
Interval 1.6 to 7.8
|
|
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
Interval 2.4 to 9.6
|
|
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
Interval 2.1 to 10.8
|
SECONDARY outcome
Timeframe: 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.
Number of surgical attempts required for procedural implant success
Outcome measures
| Measure |
Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System
n=180 Participants
Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device.
|
|---|---|
|
Number of Attempts Required for Procedural Success
Two Attempts
|
3 Participants
|
|
Number of Attempts Required for Procedural Success
One Attempt
|
177 Participants
|
SECONDARY outcome
Timeframe: During the procedure as measured by standard operating procedures at the sitesPopulation: Data reported is for the Successfully Implanted (IMP) cohort n=180.
Total time a subject is on bypass time as a measure of procedural complexity
Outcome measures
| Measure |
Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System
n=180 Participants
Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device.
|
|---|---|
|
Total Bypass Time During the Implant Procedure
|
125.1 Minutes
Standard Deviation 47.0
|
Adverse Events
Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System
Serious adverse events
| Measure |
Mitral Valve Repair With Profile 3D™ or CG Future® Annuloplasty System
n=180 participants at risk
Subjects requiring mitral valve repair and are intended to receive either Profile 3D™ or CG Future® annuloplasty device.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
0.56%
1/180 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial Fibrillation
|
0.56%
1/180 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial Flutter
|
0.56%
1/180 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac Arrest
|
0.56%
1/180 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac Failure
|
1.1%
2/180 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.7%
3/180 • Number of events 6 • 1 year
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.56%
1/180 • Number of events 1 • 1 year
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.56%
1/180 • Number of events 1 • 1 year
|
|
Cardiac disorders
Right Ventricular Dysfunction
|
0.56%
1/180 • Number of events 1 • 1 year
|
|
General disorders
Death
|
1.1%
2/180 • Number of events 2 • 1 year
|
|
Infections and infestations
Pyelonephritis
|
0.56%
1/180 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
0.56%
1/180 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.56%
1/180 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.1%
2/180 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.56%
1/180 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.1%
2/180 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.56%
1/180 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Renal Transplant
|
0.56%
1/180 • Number of events 1 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Jenell Lorenz, Sr. Clinical Research Specialist
Medtronic
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place