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 groupSponsors and collaborators
Source ClinicalTrials.gov