Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System (NCT02322840)
An Initial Evaluation of the Safety and Performance of the Transcatheter Mitral Intrepid Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
🩺 Plain-English Summary (8th-Grade Level)
PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients. EFS: The study is an Early Feasibility Study to evaluate the safety and performance of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with moderate-Severe or severe, Symptomatic Mitral Regurgitation
Who can join: Review the eligibility criteria below.
Location: Abrazo Arizona Heart Hospital - EFS — Phoenix, Arizona
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 (32 Sites)
Showing the first 25 of 32 sites.
- Abrazo Arizona Heart Hospital - EFS — Phoenix, Arizona
- Cedars-Sinai Medical Center - PILOT — Los Angeles, California
- Piedmont Atlanta Hospital - PILOT — Atlanta, Georgia
- Northwestern Memorial Hospital - PILOT — Chicago, Illinois
- University of Michigan Health System - University Hospital - PILOT — Ann Arbor, Michigan
- Corewell Health - EFS — Grand Rapids, Michigan
- Abbott Northwestern Hospital - EFS — Minneapolis, Minnesota
- Abbott Northwestern Hospital - PILOT — Minneapolis, Minnesota
- Barnes Jewish Hospital - PILOT — St Louis, Missouri
- NYU Langone Medical Center - PILOT — New York, New York
- The Mount Sinai Hospital (New York NY) - EFS — New York, New York
- The Mount Sinai Hospital (New York NY) - PILOT — New York, New York
- New York-Presbyterian Hospital Columbia University Medical Center - EFS — New York, New York
- New York-Presbyterian Hospital Columbia University Medical Center - PILOT — New York, New York
- Oregon Health & Science University Hospital - EFS — Portland, Oregon
- UPMC Pinnacle Harrisburg Campus - EFS — Wormleysburg, Pennsylvania
- Baylor Jack and Jane Hamilton Heart and Vascular Hospital - PILOT — Dallas, Texas
- Houston Methodist Hospital - PILOT — Houston, Texas
- University of Virginia Medical Center - EFS — Charlottesville, Virginia
- Aurora Saint Luke's Medical Center - EFS — Milwaukee, Wisconsin
- Aurora Saint Lukes Medical Center - PILOT — Milwaukee, Wisconsin
- Monash Health - PILOT — Clayton, Victoria
- The Alfred Hospital - PILOT — Melbourne,
- Royal Prince Alfred Hospital - PILOT — Sydney,
- Rigshospitalet - PILOT — Copenhagen,
💰 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 Valve Insufficiency
- Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair — Sacramento, California
- Long Term Follow Up for CTSN Mitral Valve Repair Studies — Los Angeles, California
- PARTNER 3 Trial - Mitral Valve in Valve — Atlanta, Georgia
- REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial — Ottawa, Ontario
- The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study — New York, New York
Explore by condition: All Mitral Valve Insufficiency 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.