ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
AI Description
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
- child, adult, older adult
- Participants
- 200
- Expected completion
- 2039-12
- Funded by
- industry
Conditions studied
Aortic Valve Insufficiency, Aortic Valve Stenosis
What is being tested
- DEVICE: SAPIEN X4/X4S THV
What it measures
- Non-hierarchical composite of death and stroke, The number of patients that died or had a stroke, 1 year
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Allegheny General Hospital
Pittsburgh, PA
Ascension Saint Thomas Hospital
Nashville, TN
Atrium Health Carolinas Medical Center
Charlotte, NC
Baylor Scott & White The Heart Hospital – Plano
Plano, TX
Brigham and Women's Hospital
Boston, MA
California Pacific Medical Center (Van Ness Campus)
San Francisco, CA
Cleveland Clinic
Cleveland, OH
Emory University Hospital Midtown
Atlanta, GA
Henry Ford Health (Detroit)
Detroit, MI
Hillcrest Medical Center
Tulsa, OK
Hoag Hospital (Newport Beach)
Newport Beach, CA
Kaiser Permanente San Francisco Medical Center
San Francisco, CA
Kaleida Health
Buffalo, NY
Mayo Clinic (Rochester, Minnesota)
Rochester, MN
MedStar Union Memorial Hospital
Baltimore, MD
Memorial Hermann-Texas Medical Center
Houston, TX
Montefiore Einstein Hospital (Moses Campus)
Bronx, NY
Morristown Medical Center
Morristown, NJ
Naples Comprehensive Health (NCH)
Naples, FL
Novant Health Presbyterian Medical Center
Charlotte, NC
Piedmont Atlanta Hospital
Atlanta, GA
Robert Wood Johnson University Hospital
New Brunswick, NJ
Rochester General Hospital
Rochester, NY
Stanford Health Care
Stanford, CA
The Christ Hospital
Cincinnati, OH
The Valley Hospital
Paramus, NJ
UCHealth Medical Center of the Rockies
Loveland, CO
University of Washington Medical Center
Seattle, WA
Registry entry updated 2026-07-27
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.