UnknownPhase 2

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

300 participantsStarted 2018-02-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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+).

What they're measuring

All-cause mortality, all stroke, and re-hospitalization

Timeframe: 1 year post procedure

Trial details

NCT IDNCT03163329

SponsorChina National Center for Cardiovascular Diseases

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2020-10-31

Contact for this trial

Yong-jian Wu, M.D, Ph.D

0086-10-88396780 fuwaihospital@hotmail.com

View on ClinicalTrials.gov More Aortic Valve Disease trials