PARTNER 3 Trial - Aortic Valve-in-Valve

This study is testing the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV). This device is used for people who have a failing artificial heart valve in their aorta (the body's main artery) that is causing severe aortic stenosis (a narrowing of the valve). You might be able to join if your existing artificial valve is failing, has a specific size, and you have certain heart symptoms (NYHA Functional Class ≥ II). Your heart care team must also agree that you are at low to intermediate risk. The study will measure success by looking at a combination of all-cause death and stroke one year after the procedure. The current status of this study is unclear, and it aims to enroll 125 participants.

Study design
This is a single-arm study, meaning all participants receive the same intervention. It aims to enroll 125 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year to assess all-cause mortality and stroke.

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NCT03003299

PARTNER 3 Trial - Aortic Valve-in-Valve

Recruiting
NAAll AgesInterventionalTreatment
Edwards Lifesciences
~125 participants
Updated 2024-05-10 on ClinicalTrials.gov
What's tested:Edwards SAPIEN 3/SAPIEN 3 Ultra THV

At a glance

Recruiting sites
30 of 51 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke
Measured over 1 year
Aortic Stenosis
Aortic Stenosis, Severe
51 sites across 27 states
New York5
California4
Illinois4
Texas4
Pennsylvania3
Virginia3
Florida2
Michigan2
  • Chris S Malaisrie, MD · PRINCIPAL_INVESTIGATOR · Northwestern University
  • Alan Zajarias, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
  • Mayra Guerrero, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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  • Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke1 year

    Number of patients that died and/or had a stroke