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



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:65 - Any
Updated:3/17/2019
Start Date:July 12, 2017
End Date:December 2031
Contact:Elizabeth Lau, PhD
Email:Elizabeth_Lau@edwards.com
Phone:949-250-3592

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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.


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.
We found this trial at
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Harrisburg, Pennsylvania 17043
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7777 Forest Ln # C840
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Gainesville, Florida 32610
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7000 Fannin St
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8700 Beverly Blvd # 8211
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1211 Medical Center Dr
Nashville, Tennessee 37232
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Sacramento, California 95814
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47 New Scotland Ave
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Charlottesville, Virginia 22903
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, Illinois 60612
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Cincinnati, Ohio 45219
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2049 E 100th St
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Columbus, Ohio 43213
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80 Seymour St
Hartford, Connecticut 6102
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Hyannis, Massachusetts 02601
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200 Hawkins Dr,
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2500 Rocky Mountain Avenue
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630 W 168th St
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201 Lyons Ave
Newark, New Jersey 07112
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