Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)

Recruiting N/A Interventional Study
Aortic Stenosis With Bicuspid Valve
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
60 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
206 (estimated)
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine · Other
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About This Trial

To compare down sizing strategy versus annular sizing strategy technique (control group) in Type 0 bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial

Trial Locations
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Eligibility Criteria
Inclusion criteria: 1. Age ≥ 65 years; 2. Age \<65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate (≥ 8%), Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment; 3. Severe, bicuspid aortic stenosis: Mean gradient ≥40 mmHg …
Contacts

Jian' an Wang, PhD, MD

+86057187783777

wja@zju.edu.cn

CONTACT