The ENCIRCLE Trial (NCT04153292)
SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access
🩺 Plain-English Summary (8th-Grade Level)
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Who can join: Review the eligibility criteria below.
Location: Heart Center Hospital — Huntsville, 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 (68 Sites)
Showing the first 25 of 68 sites.
- Heart Center Hospital — Huntsville, Alabama
- Banner University Medical Center — Phoenix, Arizona
- Saint Josephs Hospital Medical Center Dignity Health — Phoenix, Arizona
- TMC Healthcare — Tucson, Arizona
- Scripps Health — La Jolla, California
- Good Samaritan Hospital — Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California
- Kaiser Sunset LA — Los Angeles, California
- Saint Joseph Hospital — Orange, California
- California Pacific Medical Center — San Francisco, California
- UC Health Northern Colorado (Medical Center of the Rockies) — Loveland, Colorado
- Delray Medical Center — Delray Beach, Florida
- Cardiac & Vascular Institute Foundation — Gainesville, Florida
- Ascension St. Vincent's Hospital — Jacksonville, Florida
- Naples Community Hospital — Naples, Florida
- Sarasota Memorial Hospital — Sarasota, Florida
- Emory University — Atlanta, Georgia
- Piedmont Healthcare — Atlanta, Georgia
- Rush University Medical Center — Chicago, Illinois
- Northshore University Health System — Glenview, Illinois
- St. Vincent Heart Center of Indiana — Indianapolis, Indiana
- University of Kansas — Kansas City, Kansas
- Cardiovascular Research Institute of Kansas (CRIOK) — Wichita, Kansas
- Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana
- Medstar Union Memorial Hospital — Baltimore, Maryland
📞 Contact the Study Coordinator
Phone: (949) 250-2500
Email: TMTT_Clinical@edwards.com
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
- 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.
- 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.