🏛️ Verified NIH Record • Updated 2026-07-16
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation (NCT03230747)
Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Edwards Lifesciences
🩺 Plain-English Summary (8th-Grade Level)
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
Who can join: Review the eligibility criteria below.
Location: Cedars-Sinai Medical Center Heart Institute — Los Angeles, California
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 (9 Sites)
- Cedars-Sinai Medical Center Heart Institute — Los Angeles, California
- California Pacific Medical Center — San Francisco, California
- Emory University — Atlanta, Georgia
- Evanston/ Northshore University — Evanston, Illinois
- Henry Ford Hospital — Detroit, Michigan
- Mayo Clinic — Rochester, Minnesota
- Intermountain Medical Center — Murray, Utah
- Sentara Cardiovascular Research Institution — Norfolk, Virginia
- St. Paul's Hospital — Vancouver, British Columbia
💰 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
- 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.