Summary

for people ages 65 years and up (full criteria)
at UC Davis
study started
estimated completion

Description

Summary

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 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.

Official Title

Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis

Keywords

Aortic Stenosis Heart Diseases Stenosis Heart Disease Valve Tricuspid Aortic Valve Asymptomatic Aortic Valve Stenosis Constriction, Pathologic Edwards SAPIEN 3 THV TAVR

Eligibility

You can join if…

Open to people ages 65 years and up

  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.

You CAN'T join if...

  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, or is non-calcified.
  5. Severe aortic regurgitation (>3+).
  6. Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.

Locations

  • UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Kaiser San Francisco Medical Center accepting new patients
    San Francisco California 94115 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • Hoag Memorial Hospital Presbyterian accepting new patients
    Newport Beach California 92663 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT03042104
Study Type
Interventional
Last Updated