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

Use our guide to learn which trials are right for you!

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
sites
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
?
mi
from
Portland, ME
Click here to add this to my saved trials
Sacramento, California 95814
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
?
mi
from
Albany, NY
Click here to add this to my saved trials
Buffalo, New York 14203
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Burlingame, California 94010
?
mi
from
Burlingame, CA
Click here to add this to my saved trials
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1653 West Congress Parkway
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Columbus, Ohio 43213
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43214
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dallas, Texas 75093
?
mi
from
Dallas, TX
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
3300 Gallows Road
Falls Church, Virginia 22042
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Fort Myers, Florida 33908
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Hamilton, Ontario
?
mi
from
Hamilton,
Click here to add this to my saved trials
Harrisburg, Pennsylvania 17043
?
mi
from
Harrisburg, PA
Click here to add this to my saved trials
80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
?
mi
from
Hartford, CT
Click here to add this to my saved trials
Hyannis, Massachusetts 02601
?
mi
from
Hyannis, MA
Click here to add this to my saved trials
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
2500 Rocky Mountain Avenue
Loveland, Colorado 80538
?
mi
from
Loveland, CO
Click here to add this to my saved trials
Miami Beach, Florida 33140
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
259 1st Street
Mineola, New York 11501
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Missoula, Montana 59802
?
mi
from
Missoula, MT
Click here to add this to my saved trials
100 Madison Avenue
Morristown, New Jersey 07960
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
5121 Cottonwood Street
Murray, Utah 84107
?
mi
from
Murray, UT
Click here to add this to my saved trials
New Orleans, Louisiana 70121
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
550 1st Ave
New York, New York 10016
(212) 263-7300
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
?
mi
from
New York, NY
Click here to add this to my saved trials
201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Newport Beach, California 92658
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73120
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85006
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15212
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
2800 Blue Ridge Road
Raleigh, North Carolina 27607
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Roanoke, Virginia 24014
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Rochester, New York 14621
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Saint Cloud, Minnesota 56303
?
mi
from
Saint Cloud, MN
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Spokane, Washington 99204
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Springfield, Illinois 62701
?
mi
from
Springfield, IL
Click here to add this to my saved trials
300 Pasteur Dr
Stanford, California 94305
?
mi
from
Stanford, CA
Click here to add this to my saved trials
110 Irving Street Northwest
Washington, District of Columbia 20010
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Wynnewood, Pennsylvania 19096
?
mi
from
Wynnewood, PA
Click here to add this to my saved trials
York, Pennsylvania 17315
?
mi
from
York, PA
Click here to add this to my saved trials