RecruitingNot Applicable

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

China206 participantsStarted 2022-06-27

Plain-language summary

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

Who can participate

Age range60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 65 years;
✓. 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;
✓. Severe, bicuspid aortic stenosis: Mean gradient ≥40 mmHg OR Maximal aortic valve velocity ≥4.0 m/sec OR Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2); if SVi \<35mL/m2, low-dose dobutamine stress echocardiography is required;
✓. NYHA classification ≥ II;
✓. Type 0 (Sievers classification) by MDCT;
✓. Perimeter-derived annulus diameter ranges from 20.0 mm to 26.0 mm;
✓. Candidate for Transfemoral TAVR;
✓. 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)/Ethics Committee (EC) of the respective clinical site.

Exclusion criteria

✕. Any contra-indication for Self-expanding bioprosthetic aortic valve deployment Leukopenia (WBC \< 3000 cell/mL), acute anemia (Hgb \< 9 g/dL), Thrombocytopenia (Plt\< 50,000 cell/mL).
✕. Active sepsis, including active bacterial endocarditis with or without treatment;
✕. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment \[(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\].

What they're measuring

Composite endpoint of Clinical Event Rate of Device Success (VARC-3), Free of pacemaker implantation, and Free of new onset complete left bundle branch block at 1 month

Timeframe: 1 month after index procedure

Trial details

NCT IDNCT05511792

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-30

Contact for this trial

Jian' an Wang, PhD, MD

+86057187783777 wja@zju.edu.cn

View on ClinicalTrials.gov More Aortic Stenosis With Bicuspid Valve trials