Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (NCT03433274)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Baptist Medical Center Princeton — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (78 Sites)
Showing the first 25 of 78 sites.
- Baptist Medical Center Princeton — Birmingham, Alabama
- UAB University Hospital — Birmingham, Alabama
- Banner-University Medical Center — Phoenix, Arizona
- Scottsdale Healthcare Shea — Scottsdale, Arizona
- Baptist Health Medical Center — Little Rock, Arkansas
- Fresno Heart Hospital — Fresno, California
- University of Southern California University Hospital — Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California
- Sutter Medical Center, Sacramento — Sacramento, California
- University of California - Davis Medical Center — Sacramento, California
- San Diego Cardiac Center — San Diego, California
- University of California at San Francisco — San Francisco, California
- Stanford Health Care — Stanford, California
- Los Robles Regional Medical Center — Thousand Oaks, California
- University of Colorado Hospital — Aurora, Colorado
- Manatee Memorial Hospital — Bradenton, Florida
- BayCare Healthcare System - Morton Plant Hospital — Clearwater, Florida
- Delray Medical Center — Delray Beach, Florida
- HCA Florida North Florida Hospital — Gainesville, Florida
- University of Florida — Gainesville, Florida
- Baptist Hospital of Miami — Miami, Florida
- Tallahassee Research Institute — Tallahassee, Florida
- Cleveland Clinic Florida — Weston, Florida
- Piedmont Heart Institute — Atlanta, Georgia
- Emory University Hospital — Atlanta, Georgia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Mitral Regurgitation
- SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation — Los Angeles, California
- Beating Heart Mitral Valve Repair With the HARPOON™ System — San Francisco, California
- Prospective Treatment Algorithm Guiding Repair of Severe Ischemic Mitral Regurgitation — Ottawa, Ontario
- LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY — Ottawa, Ontario
- CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry — Tucson, Arizona
Explore by condition: All Mitral Regurgitation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.