🏛️ Verified NIH Record • Updated 2026-04-22
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study (NCT03635424)
Transcatheter Aortic Valve Replacement (TAVR) With Medtronic TAVR System in Patients With Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality With Surgical Aortic Valve Replacement (SAVR)
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Medtronic Cardiovascular
🩺 Plain-English Summary (8th-Grade Level)
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
Who can join: Review the eligibility criteria below.
Location: Abrazo Arizona Heart Hospital — Phoenix, Arizona
Age range: 60 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 (25 Sites)
- Abrazo Arizona Heart Hospital — Phoenix, Arizona
- Scripps Memorial Hospital La Jolla — La Jolla, California
- Los Robles Hospital & Medical Center — Thousand Oaks, California
- Yale New Haven Hospital — New Haven, Connecticut
- Morton Plant Hospital — Clearwater, Florida
- HealthPark Medical Center — Fort Myers, Florida
- Tallahassee Memorial Hospital — Tallahassee, Florida
- Piedmont Atlanta Hospital — Atlanta, Georgia
- Mercy Medical Center - Des Moines — Des Moines, Iowa
- Massachusetts General Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- University of Michigan Health System — Ann Arbor, Michigan
- Spectrum Health Hospital — Grand Rapids, Michigan
- Abbott Northwestern Hospital — Minneapolis, Minnesota
- North Shore University Hospital — Manhasset, New York
- The Mount Sinai Hospital — New York, New York
- Saint Francis Hospital — Roslyn, New York
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- OhioHealth Riverside Methodist Hospital — Columbus, Ohio
- Oregon Health & Science University Hospital — Portland, Oregon
- UPMC Pinnacle Harrisburg Campus — Harrisburg, Pennsylvania
- Paramount Heart — Villanova, Pennsylvania
- Baylor Jack and Jane Hamilton Heart & Vascular Hospital — Dallas, Texas
- Houston Methodist Hospital — Houston, Texas
- Aurora St. Luke's Medical Center — Milwaukee, Wisconsin
💰 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 Bicuspid Aortic Valve
- Identification of Genetic Causes of Bicuspid Aortic Valve Disease — Boston, Massachusetts
- Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry — Los Angeles, California
- Bicuspid Aortic Valve (BAV) Registry — Ann Arbor, Michigan
Explore by condition: All Bicuspid Aortic Valve 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.