The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
Phase 2
Not yet recruiting
- Conditions
- Aortic Valve Disease
- Interventions
- Procedure: TAVRProcedure: SAVR
- Registration Number
- NCT03163329
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- Brief Summary
Previous trials have shown that TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk. However, patients with congenital bicuspid valve have been excluded in those trials. The purpose of this trial is to determine the safety and effectiveness of TAVR in intermediate-risk patients with bicuspid aortic valve stenosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Severe, calcific bicuspid aortic stenosis.
- Heart team agrees the patient has a risk of operative mortality and has an STS <8 and >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 (IRB) of the respective clinical site.
Exclusion Criteria
- 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.
- Severe aortic regurgitation (>3+).
- Severe mitral regurgitation (>3+).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAVR group TAVR - SAVR group SAVR -
- Primary Outcome Measures
Name Time Method All-cause mortality, all stroke, and re-hospitalization 1 year post procedure This composite endpoint will be evaluated as a non-inferiority analysis based on a relative non-inferiority margin of 35%
- Secondary Outcome Measures
Name Time Method