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10,000 patients join quest to unlock heart valve disease secrets

NCT ID NCT07267117

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is following 10,000 adults with heart valve disease to see how their condition changes over time. Researchers will use scans, blood tests, and health records to track progression and the effects of treatments like surgery or medication. The goal is to better predict outcomes and improve care for people with valve problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better predict how heart valve disease will progress and guide decisions on treatments like surgery or lifestyle changes.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new therapy. Results may take years and might not lead to immediate changes in care.

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.

Participants

About 10,000 people

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

Started

Jun 2025

Expected to finish

May 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.

Who is studied

This study is a prospective observational cohort study designed to investigate the disease progression, medication and surgical intervention patterns, outcomes, and influencing factors in patients with moderate or greater cardiac valve stenosis and Grade II or higher cardiac valve regurgitation. The study population includes patients diagnosed at 15 major medical institutions in China, including the Second Affiliated Hospital of Zhejiang University School of Medicine and West China Hospital of Sichuan University. The severity of valvular heart disease is determined according to a standardized dataset (JACC Adv. 2025 Apr) developed by a joint task force comprising multiple international societies.

Ages

18 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: * At least 18 years old; * Be willing and able to provide informed consent to participate in the study; * Patients with heart valve disease diagnosed by echocardiography who meet one of the following criteria: 1. Grade II or higher Aortic valve regurgitation: regurgitant jet width \>3 mm, jet width / LVOT diameter ≥25%, jet cross-sectional area/LVOT cross-sectional area ≥5%, effective regurgitant orifice area (EROA) ≥0.1 cm², regurgitant volume per beat (R Vol)≥30 ml, or regurgitant fraction (RF) ≥30%. 2. Moderate or higher aortic valve stenosis: peak velocity ≥3.0 m/s, Mean gradient ≥20 mm Hg, aortic valve area ≤1.5 cm², Indexed aortic valve area ≤0.85 cm²/m², or velocity ratio ≤0.50. 3. Grade II or higher mitral valve regurgitation: regurgitant jet width ≥3 mm, regurgitant volume per beat ≥30 ml, regurgitant jet area/left atrial area \>30%, or effective regurgitant orifice area (EROA) ≥0.2 cm². 4. Moderate or higher valve stenosis: valve area (specific finding) ≤1.5 cm², or mean gradient (supportive finding) ≥10.0 mmHg. 5. Grade II or higher tricuspid valve regurgitation: regurgitant jet width ≥3 mm, proximal isovelocity surface area ≥6 mm, effective regurgitant orifice area (EROA) ≥0.2 cm², or regurgitant volume per beat ≥30 ml. 6. Significant tricuspid valve stenosis: mean pressure gradient ≥5.0 mmHg, inflow time-velocity integral \>60 cm, T1/2 ≥190 ms, or valve area ≤1.0 cm². 7. Grade II or higher pulmonary valve regurgitation: regurgitant jet width \>3 mm, regurgitant volume per beat ≥30 ml, regurgitant fraction ≥30%, or effective regurgitant orifice area (EROA) ≥0.1 cm². 8. Moderate or higher Pulmonary valve stenosis: pulmonary valve transvalvular pressure gradient ≥40 mmHg, right ventricular systolic pressure ≥60 mmHg, or pulmonary valve opening \<1.5 cm². Exclusion Criteria: * Patients who are unwilling to accept registration and follow-up; * Patients who cannot cooperate with information collection and follow-up due to mental illness or other conditions; * Patients whose life expectancy is less than 12 months due to non-cardiac diseases (such as cancer, liver disease, kidney disease, or end-stage lung disease).

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Conditions

The condition(s) this trial relates to.

Aortic Valve Disease aortic valve disorder aortic valve insufficiency aortic valve stenosis gastroesophageal reflux disease heart valve disorder mitral valve disorder mitral valve insufficiency mitral valve stenosis pulmonary valve disorder pulmonary valve insufficiency pulmonary valve stenosis tricuspid valve disorder tricuspid valve insufficiency tricuspid valve stenosis

As listed by the trial registrant

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

Aortic valve disease Aortic valve regurgitation Aortic valve stenosis Heart valve disease Mitral valve (MV) regurgitation Mitral valve disease Mitral valve stenosis Pulmonary valve disease Transcatheter aortic valve replacement (TAVR) Transcatheter edge-to-edge repair Transcatheter pulmonary valve replacement (TPVR) Transcatheter valve replacement Tricuspid valve disease Tricuspid valve regurgitation

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

  • Army Medical Center of PLA

    RECRUITING

    Chongqing, 400010, China

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    RECRUITING

    Beijing, China

  • Fujian Provincial Hospital, Affiliated to Fuzhou University

    RECRUITING

    Fuzhou, Fujian, China

  • Fuwai Yunnan Cardiovascular Hospital

    RECRUITING

    Kunming, Yunnan, 650032, China

  • Huaxi Hospital

    RECRUITING

    Chengdu, Sichuan, China

  • Navy General Hospital, Beijing

    RECRUITING

    Beijing, China

  • People's Hospital of Xinjiang Uygur Autonomous Region

    RECRUITING

    Ürümqi, Xinjiang, 830000, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, 430060, China

  • Second Affiliated Hospital of Zhejiang University, School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, China

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, 200080, China

  • The First Affiliated Hospital of Air Force Medicial University

    RECRUITING

    Xi'an, Shaanxi, 710032, China

  • The General Hospital of Northern Theater Command

    RECRUITING

    Shenyang, Liaoning, 110031, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, 410008, China

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