Stanford, California 94305

  • Heart Diseases

Purpose:

This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.


Criteria:

Inclusion Criteria: 1. Severe aortic stenosis 2. Patient is asymptomatic 3. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site. Exclusion Criteria: 1. Patient is symptomatic. 2. Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath. 3. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization. 4. Aortic valve is a unicuspid, bicuspid with unfavorable features for TAVR or is non-calcified. 5. Severe aortic regurgitation (>3+). 6. Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.


NCT ID:

NCT03042104


Primary Contact:

Principal Investigator
Philippe Généreux, MD
Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation

Elizabeth Lau, PhD
Phone: 949-250-3592
Email: Elizabeth_Lau@Edwards.com


Backup Contact:

Email: John_Tejeda@edwards.com
John Tejada


Location Contact:

Stanford, California 94305
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 27, 2021

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