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Heart Valve DiseaseVALVE-COMPASSNCT07267117

Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease

An observational study of Heart Valve Disease and Mitral Valve (MV) Regurgitation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 15 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging (MRI) data. Read more about this study

Who is it for?
Ages 18 years and older
How many people
10,000 participants
Where
15 sitesChina
Study dates
1 Jun 2025to 31 May 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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:
  • 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%.
  • 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.
  • 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.
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  • Moderate or higher valve stenosis: valve area (specific finding) ≤1.5 cm², or mean gradient (supportive finding) ≥10.0 mmHg.
  • 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.
  • 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.
  • 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.
  • 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.

Who cannot join

  • 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).

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

15 sites in 1 country

China15 sites, 15 recruiting

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    Beijing

    Guangzhi Zhao, +86 18910290918, guangzhilala@sina.com

    Recruiting

  • Navy General Hospital, Beijing

    Beijing

    Jing Wang, +86 13466379798, wangjing121@126.com

    Recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

    Xiangwei Liu, Doctor, +86-15111196236, xwliu@csu.edu.cn

    Recruiting

  • Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Yuhu He, +86-18817314376, heyuhu1986@126.com

    Recruiting

  • Huaxi Hospital

    Chengdu, Sichuan

    Jun Shi, Doctor, +96-18608013976, shijun@wchscu.cn

    Recruiting

  • Army Medical Center of PLA

    Chongqing, 400010

    Gengze Wu, Doctor, +86-13996006248, wugengze@163.com

    Recruiting

  • Fujian Provincial Hospital, Affiliated to Fuzhou University

    Fuzhou, Fujian

    Xinjing Chen, PhD, +86-13405927173, 3319326@163.com

    Recruiting

  • Second Affiliated Hospital of Zhejiang University, School of Medicine

    Hangzhou, Zhejiang, 310000

    Xianbao Liu, Doctor, +86-0571-87788625, liuxb@zju.edu.cn

    Recruiting

  • Fuwai Yunnan Cardiovascular Hospital

    Kunming, Yunnan, 650032

    Da Zhu, PhD, +86-17780731330, zhuda8687@126.com

    Recruiting

  • Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

    Weili Liu, +86-18661800557, liuweili2008@yeah.net

    Recruiting

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

    Shanghai, 200080

    Yu Zhuang, +86 18917323250, drzhuangyu@163.com

    Recruiting

  • The General Hospital of Northern Theater Command

    Shenyang, Liaoning, 110031

    Yang Li, +86 15309889820, liyang19830925@126.com

    Recruiting

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830000

    Xiangyu Dong, +86 18199738873, 960446978@qq.com

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

    Jing Chen, Doctor, +86-13659840327, chenjing1982@whu.edu.cn

    Recruiting

  • The First Affiliated Hospital of Air Force Medicial University

    Xi'an, Shaanxi, 710032

    Rutao Wang, Doctor, +86 15091095796, rutaowang@qq.com

    Recruiting

Other trials in China

About this study

Official title: Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease (VALVE-COMPASS)

The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging (MRI) data. Additionally, the study aims to analyze the potential impact of device-based interventions, pharmacological therapy, and lifestyle modifications on disease progression.

Read the detailed description

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.

Currently, there is a lack of clear consensus regarding the management of patients with moderate valvular stenosis and regurgitation, and their subsequent disease progression remains poorly understood. Notably, the time span for progression from moderate to severe valvular heart disease can vary from 1 to 10 years, and monitoring and early warning mechanisms for potential early markers indicating disease deterioration are currently underdeveloped. Furthermore, patients with severe valvular heart disease may experience different outcomes following various device implantations, and the associated risk factors require further clarification.

The objective of this study is to identify all clinical, biological, echocardiographic, and imaging parameters that may increase the risk of disease progression or adverse outcomes through a prospective observational cohort design. The confirmation of these parameters will guide future research in developing pharmacological and interventional treatment strategies to reduce mortality associated with this disease. Patients enrolled in this study will undergo annual outpatient follow-up visits after diagnosis, which will include electrocardiography, echocardiography, blood analysis, and contrast-enhanced CT scans. Through these comprehensive monitoring methods, we aim to accurately assess changes in patients' conditions and provide a scientific basis for clinical decision-making.

Keywords
Heart Valve Disease Progression, Heart Valve disease sequelae
Medical subject headings
Heart Valve Diseases, Gastroesophageal Reflux, Mitral Valve Stenosis, Aortic Valve Disease, Aortic Valve Stenosis, Tricuspid Valve Insufficiency, Aortic Valve Insufficiency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality

    Measured: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

  2. Heart valve replacement or repair

    Surgical Heart Valve Replacement/Repair or Transcatheter Aortic Valve Replacement/Repair

    Measured: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

  3. Stroke

    Episode of ischemic stroke or hemorrhagic stroke in the internal carotid artery territory defined on CT scan or MRI brain.

    Measured: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

  4. Re-hospitalization related to cardiovascular disease

    Requires rehospitalization due to cardiovascular diseases such as coronary atherosclerotic heart disease, heart failure, arrhythmia, pulmonary embolism, aortic disease, and hypertension.

    Measured: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

Secondary outcomes (4)

  1. Progression of valve stenosis or regurgitation

    Progression from moderate valvular stenosis to severe stenosis, or from grade II valvular regurgitation to more severe regurgitation, as defined by the echocardiographic examination.

    Measured: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

  2. Ventricular remodeling and deterioration of cardiac function

    Changes in indicators such as LVEF, LVEDD, or anteroposterior diameter of the atria as defined by echocardiography

    Measured: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

  3. Changes in quality of life and symptoms

    NYHA functional class, six-minute walk distance, or newly developed or worsening typical symptoms

    Measured: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

  4. Newly Emerging Cardiovascular Disease and Complications

    Such as newly onset arrhythmic events (including atrial fibrillation/flutter, conduction block, sick sinus syndrome, etc.), non-hospitalized heart failure-related events, bleeding events, thrombotic events, hypertensive emergencies, and symptoms related to myocardial ischemia.

    Measured: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2025
  2. Study start1 Jun 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07267117
Sponsor's protocol ID
2025-0528
Acronym
VALVE-COMPASS
Status last verified
Jun 2025
First submitted
25 Nov 2025
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lansac E, Veen KM, Joseph A, Blancarte Jaber P, Sossi F, Das-Gupta Z, Aktaa S, Sadaba JR, Thourani VH, Dahle G, Szeto WY, Bakaeen F, Aikawa E, Schoen FJ, Girdauskas E, Almeida A, Zuckermann A, Meuris B, Stott J, Kluin J, Meel R, Woan W, Colgan D, Jneid H, Balkhy H, Szerlip M, Preventza O, Shah P, Rigolin VH, Medica S, Holmes P, Sitges M, Pibarot P, Donal E, Hahn RT, Takkenberg JJM. The First International Consortium for Health Outcomes Measurement (ICHOM) Standard Dataset for Reporting Outcomes in Heart Valve Disease: Moving From Device- to Patient-Centered Outcomes: Developed by a multisociety taskforce coordinated by the Heart Valve Society (HVS) including the American Heart Association (AHA), the American College of Cardiology (ACC), the European Association for Cardio-Thoracic Surgery (EACTS), the European Society of Cardiology (ESC), The Society of Thoracic Surgeons (STS), the Australian & New Zealand Society of Cardiac & Thoracic Surgeons (ANZSCTS), the International Society for Applied Cardiovascular Biology (ISACB), the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS), the South African Heart Association (SHA), Heart Valve Voice, and Global Heart Hub. JACC Adv. 2025 Apr;4(4):101059. doi: 10.1016/j.jacadv.2024.101059. Epub 2025 Feb 17.

    PubMed 39966045

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Valve Disease and Mitral Valve (MV) Regurgitation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality (time frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07267117, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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