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New study aims to improve heart valve replacement for patients with bicuspid aortic stenosis

NCT ID NCT05511792

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a slightly smaller artificial heart valve (downsizing) works better than the standard method for people with a bicuspid aortic valve—a heart valve with only two flaps instead of three. About 206 adults with severe narrowing of this valve will be randomly assigned to one of two sizing strategies during a minimally invasive valve replacement procedure. The goal is to see which approach leads to fewer complications like needing a pacemaker or having a blocked heart signal.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 206 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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; 4. NYHA classification ≥ II; 5. Type 0 (Sievers classification) by MDCT; 6. Perimeter-derived annulus diameter ranges from 20.0 mm to 26.0 mm; 7. Candidate for Transfemoral TAVR; 8. 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: 1. 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). 2. Active sepsis, including active bacterial endocarditis with or without treatment; 3. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment \[(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\]. 4. Stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure. 5. Estimated life expectancy \< 12 months (365 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease. 6. Any Emergent surgery required before TAVR procedure. 7. A known hypersensitivity or contraindication to any of the following that cannot be adequately medicated:aspirin or heparin (HIT/HITTS) and bivalirudin; clopidogrel; Nitinol (titanium or nickel); contrast media 8. Gastrointestinal (GI) bleeding that would preclude anticoagulation. 9. Subject refuses a blood transfusion. 10. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits). 11. Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams. 12. Currently participating in an investigational drug or another device study (excluding registries). 13. Hypertrophic cardiomyopathy (HCM with myocardium more than 1.5cm without an identifiable cause) with obstruction (HOCM). 14. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. 15. Severe mitral stenosis amenable to surgical replacement or repair. 16. Aortic valve type cannot be determined (Sievers classification). 17. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma \[especially if thick (\> 5 mm), protruding or ulcerated\] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe"unfolding" and horizontal aorta(Annular Angulation\>70°). 18. Ascending aorta diameter \> 50 mm. 19. Aortic or iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath. 20. Patient is considered high risk for TAVR by CT corelab, including coronary obstruction, annular rupture and other severe TAVR-Related complications. 21. Previous pacemaker implantation.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis with bicuspid valve

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, Shandong, 266000, China

  • First Affiliated Hospital of Xi 'an Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, China

  • Fujian Provincial Hospital, Affiliated to Fuzhou University

    RECRUITING

    Fuzhou, Fujian, China

  • Lanzhou University First Hospital

    RECRUITING

    Lanzhou, Gansu, 730000, China

  • Nanfang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Ning Bo First Hospital

    RECRUITING

    Ningbo, Zhejiang, 315010, China

  • Qingdao Municipal Hospital

    RECRUITING

    Qingdao, Shandong, 266000, China

  • SUN YAT-SEN MEMORIAL HOSPITAL SUN YAT-SEN University

    RECRUITING

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine.

    RECRUITING

    Hangzhou, Zhejiang, 310006, China

  • The Second XIANGYA Hospital Of Central South University

    RECRUITING

    Changsha, Hunan, China

  • Xiamen Cardiovascular Hospital Xiamen University

    RECRUITING

    Xiamen, Fujian, China

  • Xinjiang Uygur Autonomous Region People's Hospital

    RECRUITING

    Ürümqi, Xinjiang, China

  • Yulin First People's Hospital

    RECRUITING

    Yulin, Guangxi, 537000, China

  • Zhengzhou Seventh People's Hospital

    RECRUITING

    Zhengzhou, Henan, 450016, China

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