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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P230007 / PAS001 |
| Date Original Protocol Accepted |
04/01/2024
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| Date Current Protocol Accepted |
05/31/2024
|
| Study Name |
Continued f/u of the Premarket Cohort
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| Device Name |
TriClip G4 System
|
| Clinical Trial Number(s) |
NCT03904147
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
Sponsor Registry
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this trial was to evaluate the safety and effectiveness of the TriClip device in symptomatic patients with severe TR who were determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.
The study includes continued follow-up of patients enrolled under the IDE, including the TRILUMINATE pivotal trial and the Continued Access Protocol (CAP) investigation. The TRILUMINATE pivotal trial was a prospective, multicenter, randomized, controlled, clinical trial to test the superiority of the TriClip device in addition to medical therapy over medical therapy alone. The CAP began once the Randomized and Single-Arm cohorts of the pivotal trial finished enrolling. All subjects enrolled into the CAP received the TriClip device.
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| Study Population |
The study population consists of patients with symptomatic, severe tricuspid valve regurgitation whose symptoms and TR severity persist despite being optimally treated with medical therapy and who are at intermediate or greater risk for tricuspid valve surgery as determined by a heart team.
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| Sample Size |
The study will continue to follow all living patients who were enrolled under the IDE.
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| Key Study Endpoints |
Data will be collected per the study protocol and summarized descriptively, including, but not limited to, adverse event data including deaths, tricuspid valve reintervention, heart failure related hospitalizations, echocardiographic endpoints including tricuspid regurgitation severity grade, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, SF-36 score (1 and 2 years only), New York Heart Association (NYHA) classification, and 6-Minute Walk Test (6MWT) distance. KCCQ score and TR severity grade will be collected with a minimum of 75% completeness rate each year through 5 years.
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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
Randomized cohort, 2-year outcomes:
- All-cause mortality: Device 17.2%, Control 15.7%
- Heart failure hospitalization: Device 21.4%, Control 22.6%
- Total hospitalizations: Device 56.1%, Control 76.3%
Single-arm cohort, 2-year outcomes:
- All-cause mortality: 21.3%
- Heart failure hospitalization: 27.7%
- Total hospitalizations: 62.2%
Continued access cohort, 1-year outcomes:
- All-cause mortality: 7.7%
- Heart failure hospitalization: 13.0%
- Total hospitalizations: 33.6%
Effectiveness Results
Randomized cohort, 2-year outcomes:
- Device group: 85.4% achieved moderate or less TR; KCCQ improved from 55.6 to 72.9 points
- Control group: 61.4% achieved moderate or less TR (67% post-crossover); KCCQ improved from 54.6 to 71.5 points
Single-arm cohort, 2-year outcomes:
- 71.8% achieved moderate or less TR; KCCQ improved from 52.6 to 74.1 points
Continued access cohort, 1-year outcomes:
- 73.0% achieved moderate or less TR; KCCQ improved from 57.2 to 72.8 points
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| Actual Number of Patients Enrolled |
Actual Number of Subjects Enrolled Number of subjects randomized or with attempted procedure (single-arm and CAS cohorts):
Randomized cohort: N=572
Single-arm cohort: N=188
Continued access (CAS) cohort: N=378
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| Actual Number of Sites Enrolled |
75
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| Patient Follow-up Rate |
Follow-up Rate At 2-years
Randomized cohort: 87%
Single-arm cohort: 93%
At 1-year
Continued access cohort: 90%
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