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
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