🏛️ Verified NIH Record • Updated 2024-05-08
PARTNER 3 Trial - Aortic Valve-in-Valve (NCT03003299)
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Edwards Lifesciences
🩺 Plain-English Summary (8th-Grade Level)
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (32 items).
Location: Banner University Medical Center — Phoenix, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
- Severe regurgitation (\> 3+) or stenosis of any other valve
- Failing valve has moderate or severe paravalvular regurgitation
- Failing valve is unstable, rocking, or not structurally intact
- Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
- Increased risk of embolization of THV
- Known bioprosthetic valve with residual mean gradient \> 20 mmHg at the end of the index procedure for implantation of the original valve
- Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
- Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
- Anatomical characteristics that would preclude safe access to the apex (Transapical)
- Evidence of an acute myocardial infarction ≤ 30 days before enrollment
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (51 Sites)
- Banner University Medical Center — Phoenix, Arizona
- University of California Los Angeles — Los Angeles, California
- Sutter Medical Center — Sacramento, California
- Kaiser Permanente San Francisco — San Francisco, California
- Stanford University Medical Center — Stanford, California
- UC Health Northern Colorado/Medical Center of the Rockies — Loveland, Colorado
- Hartford Hospital — Hartford, Connecticut
- JFK Medical Center/ Atlantic Clinical Research Collaborative — Atlantis, Florida
- University of Florida, Gainesville — Gainesville, Florida
- Emory University Hospital — Atlanta, Georgia
- Northwestern University Hospital — Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois
- Northshore University HealthSystem — Evanston, Illinois
- Prairie Education and Research Cooperative — Springfield, Illinois
- Ochsner Clinic Foundation — New Orleans, Louisiana
- Brigham and Women's Hospital — Boston, Massachusetts
- Henry Ford Hospital — Detroit, Michigan
- William Beaumont Hospital — Royal Oak, Michigan
- University of Minnesota Medical Center — Minneapolis, Minnesota
- Mayo Clinic — Rochester, Minnesota
- Saint Luke's Hospital of Kansas City Mid America — Kansas City, Missouri
- Washington University/ Barnes-Jewish Hospital — St Louis, Missouri
- Nebraska Heart Institute — Lincoln, Nebraska
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire
- Newark Beth Israel — Newark, New Jersey
💰 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.