ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves (NCT05172973)
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
🩺 Plain-English Summary (8th-Grade Level)
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
Who can join: Review the eligibility criteria below.
Location: Hoag Memorial Hospital Presbyterian — Newport Beach, California
🧪 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 (36 Sites)
Showing the first 25 of 36 sites.
- Hoag Memorial Hospital Presbyterian — Newport Beach, California
- Bay Area Structural Heart at Sutter Health — San Francisco, California
- Kaiser San Francisco — San Francisco, California
- Stanford University Medical Center — Stanford, California
- UC Health Medical Center of the Rockies — Loveland, Colorado
- Naples Community Hospital Healthcare System — Naples, Florida
- Emory University Atlanta — Atlanta, Georgia
- Piedmont Heart Institute — Atlanta, Georgia
- Northwestern University Chicago — Evanston, Illinois
- Alexian Brothers Hospital Network — Lisle, Illinois
- Cardiovascular Research Institute of Kansas — Wichita, Kansas
- MedStar Union Memorial Hospital — Baltimore, Maryland
- Brigham and Women's Hospital — Boston, Massachusetts
- Henry Ford Hospital Detroit — Detroit, Michigan
- Mayo Clinic — Rochester, Minnesota
- Atlantic Health System Morristown — Morristown, New Jersey
- Robert Wood Johnson University Hospital — New Brunswick, New Jersey
- The Valley Hospital — Ridgewood, New Jersey
- University of Buffalo — Buffalo, New York
- Cornelll University New York — New York, New York
- Columbia University Medical Center / NYPH — New York, New York
- Montefiore Medical Center — New York, New York
- Rochester General Hospital — Rochester, New York
- Carolinas Health System — Charlotte, North Carolina
- Novant Health and Vascular Institute — Charlotte, North Carolina
📞 Contact the Study Coordinator
Phone: (949) 250-2500
Email: THV_CT.gov@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.
Explore by condition: All Aortic Valve Insufficiency 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.