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
65
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5121 Cottonwood Street
Murray, Utah 84107
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201 Dowman Dr
Atlanta, Georgia 30303
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
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Gainesville, Florida 32610
(352) 392-3261
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
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Sacramento, California 95814
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Seattle, Washington 98104
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47 New Scotland Ave
Albany, New York 12208
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Buffalo, New York 14203
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Burlingame, California 94010
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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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1653 West Congress Parkway
Chicago, Illinois 60612
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Cincinnati, Ohio 45219
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Columbus, Ohio 43213
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Dallas, Texas 75093
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2799 W Grand Blvd
Detroit, Michigan 48202
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3300 Gallows Road
Falls Church, Virginia 22042
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Fort Myers, Florida 33908
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Hamilton, Ontario
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Harrisburg, Pennsylvania 17043
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
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Hyannis, Massachusetts 02601
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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2500 Rocky Mountain Avenue
Loveland, Colorado 80538
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Miami Beach, Florida 33140
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259 1st Street
Mineola, New York 11501
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Missoula, Montana 59802
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100 Madison Avenue
Morristown, New Jersey 07960
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630 W 168th St
New York, New York
212-305-2862
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New York, New York 10021
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550 1st Ave
New York, New York 10016
(212) 263-7300
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
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Newport Beach, California 92658
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Oklahoma City, Oklahoma 73120
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3451 Walnut St
Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85006
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Pittsburgh, Pennsylvania 15212
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2800 Blue Ridge Road
Raleigh, North Carolina 27607
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Roanoke, Virginia 24014
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Rochester, Minnesota 55905
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300 Pasteur Dr
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