PARTNER 3 Trial - Aortic Valve-in-Valve
Recruiting
N/A
Interventional Study
Aortic Stenosis
Aortic Stenosis, Severe
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 125 (estimated)
- Sponsor
- Edwards Lifesciences · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
2. Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
3. NYHA Functional Class ≥ II.
4. Heart Team a…
Contacts