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

A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients Who Have Severe, Calcific, Bicuspid, Aortic Stenosis Requiring Aortic Valve Replacement

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+).