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

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 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.

Conditions

  • Aortic Stenosis
  • Heart Diseases

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TAVR
Transcatheter aortic valve replacement (TAVR) arm will have intervention with the Edwards SAPIEN 3 THV.
  • Device: Edwards SAPIEN 3 THV
    Patients in experimental arm will receive SAPIEN 3 THV.
    Other names:
    • SAPIEN 3
No Intervention
CS
Clinical surveillance

Recruiting Locations

More Details

NCT ID
NCT03042104
Status
Recruiting
Sponsor
Edwards Lifesciences

Study Contact

Elizabeth Lau, PhD
949-250-3592
Elizabeth_Lau@edwards.com