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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P240042 / PAS001 |
| Date Original Protocol Accepted |
05/23/2025
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| Date Current Protocol Accepted |
|
| Study Name |
Continued Follow-up of SUMMIT MAC Premarket Cohort
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| Device Name |
Tendyne Transcatheter Mitral Valve System
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| Clinical Trial Number(s) |
NCT03433274
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of all living Severe MAC cohort subjects who were enrolled under the IDE, including those enrolled in the continued access protocol (CAP) investigation. The objective of this study is to characterize the clinical outcomes annually through 5 years post-procedure.
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| Study Population |
All living Severe MAC cohort subjects who were enrolled under the IDE.
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| Sample Size |
All living subjects.
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| Key Study Endpoints |
All-cause mortality, all stroke, cardiovascular hospitalization, number of days alive and out of hospital, annualized rate of HFH, mitral valve reintervention or reoperation, 6MWT distance, KCCQ score, EQ-5D-5L score, SF-12 score, NYHA functional class, and echocardiographic endpoints.
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| Follow-up Visits and Length of Follow-up |
5 years.
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| Interim or Final Data Summary |
| Interim Results |
Safety Results:
Severe MAC at 2Y (KM Rate):
All-cause mortality: 31.8%
Cardiovascular: 23.5%
Non-Cardiovascular: 10.8%
Cardiovascular Hospitalization: 49.4% Heart Failure Hospitalization: 34.7%
Other Cardiovascular Hospitalization: 26.8% All stroke: 10.6%
Mitral Valve Reintervention: 6.8%
MAC CAP at 1Y (KM Rate):
All-cause mortality: 33.8%
Cardiovascular: 29%
Non-Cardiovascular: 6.7%
Cardiovascular Hospitalization: 38% Heart Failure Hospitalization: 20.3%
Other Cardiovascular Hospitalization: 24.6% All stroke: 2.9%
Mitral Valve Reintervention: 2.9%
Effectiveness Results:
Severe MAC at 2Y:
NYHA: At baseline, 73.8% of the subjects were in NYHA Class III or IV and at the 2-Year Follow-up, 83.1% of subjects in NYHA Class I or II.
Six-Minute Walk: The mean 6MWT distance at baseline was 203.6 -/+ 111.8. At follow-up, the mean 6MWT
distance was 213.6 -/+ 117.0 (at 2-Year).
KCCQ: At baseline, subjects had a mean KCCQ overall score of 49.2 -/+ 23.1. At follow up, the mean
KCCQ overall score increased to 67.9 -/+ 25.1 (2-Year).
EQ-5D: The mean utility index score was 0.73 -/+ 0.16 at baseline, compared to 0.75 -/+ 0.18 at
2-Years. At baseline, the mean EQ-VAS scores were 61.1 -/+ 20.5. The average score was higher at
follow-up (68.5 -/+ 20.0 at 2-Years).
SF-12: At baseline, the mean SF-12 physical component score was 32.0 -/+ 9.7, indicating populations with somewhat poor physical condition. This
increased to 33.7 -/+ 10.6 at 2-Years. The mean mental component score was 48.3 -/+ 12.8 at baseline,
which increased to 52.3 -/+ 11.2 at 2-Years.
Mitral Regurgitation: At baseline, 87.1% of the subjects had MR Grade 3+ or 4+ in severity. In
follow-up visits, all subjects had MR less than or equal to 2+.
Mean mitral gradient: The mean mitral valve gradient decreased from 6.0 mmHg at baseline to 3.9
mmHg at 2-Year follow-up.
PVL: The observed major PVL (Grade greater than or equal to 2+) rate was 3.7% at the 2-Year Follow-up (events did not lead
to reintervention).
MAC CAP at 1Y:
NYHA: At baseline, 72.5% of the subjects were in NYHA Class III or IV and at the 1-Year follow-up
94.7% of subjects were NYHA Class I or II.
Six-Minute Walk: The mean 6MWT distance at baseline was 203.7 -/+ 114.4 meters. At follow-up, the
mean 6MWT distance was 232.6 -/+ 142.7 (at 1-Year) meters.
KCCQ: At baseline, subjects had a mean KCCQ overall score of 53.6 -/+ 21.3 points.
At follow up, the mean KCCQ overall score increased to 66.0 -/+ 37.6 (1-Year).
EQ-5D: The mean utility index score was 0.75 -/+ 0.15 at baseline, compared to 0.73 -/+ 0.20 at 1-Year.
At baseline, the mean EQ-VAS score was 61.5 -/+ 20.8.
The average score was higher at follow-up (69.5 -/+ 19.4 at 1-Year).
SF-12: At baseline, the mean SF-12 physical component score was 30.8 -/+ 10.6, indicating populations
with somewhat poor physical condition. This increased to 31.7 -/+ 13.5 at 1-Year. The mean mental
component score was 50.5 -/+ 11.1 (MAC CAP) at baseline, which increased to 53.5 -/+ 10.6 at 1-Year.
Mitral Regurgitation: At baseline, 37.5% of the subjects had MR Grade 3+ or 4+ and 45.0% had MR
Grade 2+ in severity. In follow-up visits, most subjects had MR less than or equal to 1+ (96.8% at pre-discharge, 100%
at 30-Days, and 100% at 1-Year Follow-up).
Mean mitral gradient: The mean mitral valve gradient decreased from 9.3 mmHg at baseline to 5.3
mmHg at 1-Year follow-up.
PVL: There was no observed major PVL (Grade greater than or equal to 2+) at the 1-Year Follow-up. No device embolism or migration were observed.
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| Actual Number of Patients Enrolled |
103 subjects (Severe MAC cohort), 40 subjects (MAC CAP cohort)
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| Actual Number of Sites Enrolled |
45 sites
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| Patient Follow-up Rate |
Severe MAC: 90.3% at 2Y
MAC CAP: 87% at 1Y
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