TAVR for Aortic Stenosis
(PII S3i Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.
Who Is on the Research Team?
Martin B Leon, MD
Principal Investigator
Columbia University
Craig Smith, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for patients with severe, symptomatic aortic stenosis who are at intermediate risk. They must have heart valve issues confirmed by specific tests and be able to follow up for five years post-procedure. It's not suitable for those deemed inoperable, unstable, needing emergency surgery, or with complex coronary artery disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Edwards SAPIEN 3 transcatheter heart valve via transfemoral, transapical, or transaortic delivery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Edwards SAPIEN 3
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edwards Lifesciences
Lead Sponsor
Todd Brinton
Edwards Lifesciences
Chief Medical Officer since 2023
MD from Stanford University
Bernard Zovighian
Edwards Lifesciences
Chief Executive Officer since 2023
MBA from INSEAD