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Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
NCT03433274 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03433274
The ClinicalTrials.gov registry entry for NCT03433274 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03433274 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03433274?
The interventions under investigation include: Tendyne Mitral Valve System (DEVICE), MitraClip System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03433274?
This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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