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NCT03433274 · ClinicalTrials.gov registry record · NA
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
A NA study of Cardiovascular Diseases and Mitral Regurgitation, sponsored by Abbott Medical Devices.
- Active
- Registry status
- NA
- Development phase
- 103
- Enrollment target
- 20
- Study locations
NCT03433274: Active NA study of Cardiovascular Diseases and Mitral Regurgitation, sponsored by Abbott Medical Devices.
NCT03433274 is a NA study of Cardiovascular Diseases and Mitral Regurgitation that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 103 participants, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03433274, a NA study of Cardiovascular Diseases and Mitral Regurgitation, is active but no longer recruiting, sponsored by Abbott Medical Devices.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 103 participants
- Enrollment target
- 20
- Study locations
Study Summary
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Plan (MAC CAP). Subjects in the Randomized cohort were randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts were receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) was to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial would provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System would be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who were not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and were also not suitable for transcatheter repair with MitraClip, would be enrolled in the Non-repairable cohort. Subjects would be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.
Primary Outcome
The primary endpoint for the Severe MAC cohort is freedom from all-cause mortality and heart failure hospitalization (HFH), evaluated against a performance goal of 43%.
Conditions Studied
Interventions
- DEVICE Tendyne Mitral Valve System
- DEVICE MitraClip System
Study Locations (20)
California
- Fresno Heart Hospital - Fresno
- University of Southern California University Hospital - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
- Sutter Medical Center, Sacramento - Sacramento
- University of California - Davis Medical Center - Sacramento
- San Diego Cardiac Center - San Diego
- University of California at San Francisco - San Francisco
- Stanford Health Care - Stanford
- Los Robles Regional Medical Center - Thousand Oaks
Florida
- Manatee Memorial Hospital - Bradenton
- BayCare Healthcare System - Morton Plant Hospital - Clearwater
- Delray Medical Center - Delray Beach
- HCA Florida North Florida Hospital - Gainesville
- University of Florida - Gainesville
Alabama
- Baptist Medical Center Princeton - Birmingham
- UAB University Hospital - Birmingham
Arizona
- Banner-University Medical Center - Phoenix
- Scottsdale Healthcare Shea - Scottsdale
Arkansas
- Baptist Health Medical Center - Little Rock
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2028-06 |
| Phase | NA |
What the registry record for NCT03433274 still lists
NCT03433274 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower).
The record links to 8 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 2 interventions - of which Tendyne Mitral Valve System is the first listed.
NCT03433274 names 20 study sites across 6 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT03433274 about?
NCT03433274 is a clinical study titled "Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation". Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Plan (MAC CAP). Subjects in the Randomized cohort were randomized in a 1:1 ratio to the ...
What is the current status of trial NCT03433274?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 103 participants. The study started on 2018-06-15. Estimated completion is 2028-06.
What conditions does trial NCT03433274 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Mitral Regurgitation, Heart Valve Diseases, Mitral Valve Insufficiency, Valve Disease, Heart.
What interventions are being tested in trial NCT03433274?
The interventions under investigation include: Tendyne Mitral Valve System (DEVICE), MitraClip System (DEVICE).
Who is sponsoring clinical trial NCT03433274?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03433274 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03433274's enrollment target sits among peer trials
103 192nd of 300 higher than 109 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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