🏛️ Verified NIH Record • Updated 2026-08-17
Beating Heart Mitral Valve Repair With the HARPOON™ System (NCT04375332)
A Prospective, Multi-center Trial to Evaluate the Safety and Effectiveness of Beating Heart Mitral Valve Repair With the HARPOON™ System (RESTORE)
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Edwards Lifesciences
🩺 Plain-English Summary (8th-Grade Level)
The objective of the study is to evaluate the safety and effectiveness of the HARPOON™ System in the treatment of patients with severe degenerative mitral regurgitation (DMR).
Who can join: Review the eligibility criteria below.
Location: UCSF — San Francisco, California
Age range: 21 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 (9 Sites)
- UCSF — San Francisco, California
- Piedmont Heart Institute — Atlanta, Georgia
- University of Maryland Medical Center — Baltimore, Maryland
- Johns Hopkins — Baltimore, Maryland
- University of Michigan Health System — Ann Arbor, Michigan
- Mayo Clinic — Rochester, Minnesota
- OHSU Knight Cardiovascular Institute — Portland, Oregon
- Centennial Medical Center — Nashville, Tennessee
- Intermountain Heart Institute — Murray, Utah
📞 Contact the Study Coordinator
Phone: (877) 827-3222
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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
- Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation — Birmingham, Alabama
- SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation — Los Angeles, 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.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.