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 |
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.
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
2500 Rocky Mountain Avenue
Loveland, Colorado 80538
Loveland, Colorado 80538
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Medical City Dallas Hospital If you have concerns for your health, that of a family...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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100 Madison Avenue
Morristown, New Jersey 07960
Morristown, New Jersey 07960
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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