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Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis
Overall Recruitment Status: Active, enrollment completed
 
Official Title
Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis
 
Region Sponsors
Northwest
Edwards Lifesciences
 
Acronym KP IRB No.
EARLY TAV 1474826
 
Study Type Phase
Clinical Trial Phase IV
 
Study Population Description
(Older Adult) with Aortic Stenosis, Heart Diseases
 
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 / 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.
 
Detailed Description
 
Gender Age Limit
Male & Female 65 years & older
 
Inclusion Criteria
  • Severe aortic stenosis
  • Patient is asymptomatic
  • 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
  • Patient is symptomatic
  • Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath
  • Evidence of an acute myocardial infarction = 1 month (30 days) before randomization
  • Aortic valve is a unicuspid, bicuspid with unfavorable features for TAVR or is non-calcified
  • Severe aortic regurgitation (>3+)
  • Severe mitral regurgitation (>3+) or > moderate mitral stenosis

 
Keywords and/or Specific Medical Conditions
  • Aortic Valve Stenosis
  • Pathological Conditions, Anatomical
  • Cardiovascular Diseases
  • Stenosis
  • Constriction, Pathologic
  • Ventricular Outflow Obstruction
  • Heart Disease
  • Cardiology
  • Heart Valve Diseases
 
KP Clinical Facility
  • Sunnyside Medical Center
 
Clinical Area
  • Cardiology


Principal Investigator:
Abhimanyu Uberoi, MD
Contact Information:
- Britt Ash, RN
-Sunnyside Medical Center


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