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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Saint Louis, Missouri 63110
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201 Dowman Dr
Atlanta, Georgia 30303
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75 Francis street
Boston, Massachusetts 02115
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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
Los Angeles, California 90048
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1211 Medical Center Dr
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22 Bramhall St
Portland, Maine 04102
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Sacramento, California 95814
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Seattle, Washington 98104
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47 New Scotland Ave
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Charlotte, North Carolina 28204
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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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2799 W Grand Blvd
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80 Seymour St
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Hyannis, Massachusetts 02601
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200 Hawkins Dr,
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1 Medical Center Dr
Lebanon, New Hampshire 03756
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2500 Rocky Mountain Avenue
Loveland, Colorado 80538
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630 W 168th St
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550 1st Ave
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201 Lyons Ave
Newark, New Jersey 07112
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3451 Walnut St
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2800 Blue Ridge Road
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