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8110 Gatehouse Road, Falls Church, VA 22042

Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis: EARLY TAVR trial

General Information

Age Group

Adult

Status

Active

Protocol Number

17-2779

Background Information

Objective: To establish the safety and effectiveness of the Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, California) Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis

Study Device: Edwards SAPIEN 3 THV system (20, 23, 26 and 29 mm) with the Commander delivery system

Study Design: 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 CS. Patients will be stratified by whether or not they are able to perform a treadmill stress test. In addition, patients who are screened for enrollment but have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

Offered At

Inova Fairfax Hospital, 3300 Gallows Road, Falls Church, VA 22042

Principal Investigator

Shahram Yazdani, MD and Eric Sarin, MD

Eligibility Information

Eligibility Information

  1. 65 years of age or older at time of randomization
  2. Severe aortic stenosis defined as:
    • Aortic valve area (AVA) ≤1.0 cm2 or AVA index ≤0.6 cm2/m2 AND
    • Peak jet velocity ≥4.0 m/s or Mean gradient ≥40 mmHg
  3. Patient is asymptomatic
  4. LV ejection fraction ≥50%

Ineligibility Information

  1. Patient is symptomatic
  2. Patient has any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication.
  3. Evidence of an acute myocardial infarction ≤30 days before randomization
  4. Stroke or transient ischemic attack (TIA) within 90 days of randomization
  5. Renal insufficiency
  6. Severe lung disease
  7. History of cirrhosis or any active liver disease