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 range

60 Years

Sex

ALL

See this in plain English?

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

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;

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria