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| Overall Recruitment Status: Enrollment complete |
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| Official Title |
| Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis |
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| Region |
Sponsors |
| California - Northern |
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| Acronym |
NCT No. |
| EARLY TAVR |
NCT03042104 |
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| Study Type |
Phase |
| INTERVENTIONAL |
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| Purpose |
| 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. |
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| Detailed Description |
| The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, California) Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis. |
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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
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Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath
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Evidence of an acute myocardial infarction <= 1 month (30 days) before randomization
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Aortic valve is a unicuspid, bicuspid, or is non-calcified
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Severe aortic regurgitation (>3+)
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Severe mitral regurgitation (>3+) or >= moderate mitral stenosis
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Pathological Conditions, Anatomical
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Ventricular Outflow Obstruction
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