Brief Title
Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis
Official Title
Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis
Brief Summary
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 / SAPIEN 3 Ultra 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.
Study Type
Interventional
Primary Outcome
Freedom from a non-hierarchical composite endpoint of all-cause death, all stroke, and unplanned cardiovascular hospitalization.
Secondary Outcome
Death or disabling stroke
Condition
Aortic Stenosis
Intervention
Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
Study Arms / Comparison Groups
TAVR
Description: Transcatheter aortic valve replacement (TAVR) arm will have intervention with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
1109
Start Date
July 12, 2017
Completion Date
December 2031
Primary Completion Date
December 2021
Eligibility Criteria
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 with unfavorable features for TAVR or is non-calcified. 5. Severe aortic regurgitation (>3+). 6. Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
Gender
All
Ages
65 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Philippe Généreux, MD, 949-250-3592, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03042104
Organization ID
2016-07
Responsible Party
Sponsor
Study Sponsor
Edwards Lifesciences
Study Sponsor
Philippe Généreux, MD, Principal Investigator, Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation
Verification Date
September 2020