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.
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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

Edwards THV Clinical Affairs

(949) 250-2500

THV_CT.gov@Edwards.com

CONTACT