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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03163329

Enrollment

300

Registered

2017-05-23

Start date

2018-02-01

Completion date

2024-10-31

Last updated

2018-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease

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.

Interventions

PROCEDURETAVR

Transcatheter Aortic Valve Replacement

PROCEDURESAVR

Surgical Aortic Valve Replacement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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+).

Design outcomes

Primary

Measure	Time frame	Description
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%

Contacts

Primary ContactYong-jian Wu, M.D, Ph.D

fuwaihospital@hotmail.com0086-10-88396780

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026