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

National Center for Cardiovascular Diseases

Status and phase: Not yet enrolling; Phase 2

Conditions: Aortic Valve Disease

Treatments: Procedure: TAVR; Procedure: SAVR

Study type: Interventional

Funder types: Other

Identifiers

NCT03163329

AS-20170520

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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+).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

TAVR group

Experimental group

Treatment:

Procedure: TAVR

SAVR group

Active Comparator group

Treatment:

Procedure: SAVR