PARTNER 3 Trial - Aortic Valve-in-Valve
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEdwards Lifesciences
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.
Eligibility criteria
Qualifiers
Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
NYHA Functional Class ≥ II.
Heart Team agrees the patient is low to intermediate risk.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Edwards SAPIEN 3/SAPIEN 3 Ultra THV
Treatment groups
125 Participants
are divided into 1 treatment groupLocations
51Canada
St. Paul's Hospital, Providence Health CareV6Z 1Y6, VancouverBritish Columbia, Canada
United States
Arizona
Banner University Medical Center85006, Phoenix United States
California
University of California Los Angeles90095, Los Angeles United States
Sutter Medical Center95919, Sacramento United States
Sponsors and collaborators
Edwards Lifesciences
Lead sponsor
Source ClinicalTrials.gov