The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis
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.
Inclusion Criteria:

 1. Severe, calcific bicuspid aortic stenosis.

 2. Heart team agrees the patient has a risk of operative mortality and has an STS <8 and
 >3.

 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:

 1. Ilio-femoral vessel characteristics that would preclude safe placement of the
 introducer sheath.

 2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.

 3. Severe aortic regurgitation (>3+).

 4. Severe mitral regurgitation (>3+).