Actively Recruiting

Age: 18Years +
All Genders
ID07267117

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

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-12-05

10000

Participants Needed

15

Research Sites

126 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead Sponsor

A

Army Medical Center of PLA

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the progression of moderate or greater cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, CT, and MRI data. The study aims to better understand disease progression, outcomes, and the effects of device interventions, medications, and lifestyle changes. It addresses the current lack of consensus on managing moderate valvular heart disease and the need for improved early warning mechanisms. This observational cohort study involves patients diagnosed with heart valve disease at major medical centers in China. Participants will be followed annually with outpatient visits including electrocardiography, echocardiography, blood tests, and contrast-enhanced CT scans. The study collects standardized data to identify factors that influence disease progression and adverse outcomes, guiding future treatment research. Participants will be monitored over several years with yearly assessments to track mortality, heart valve surgery, stroke, rehospitalization, valve disease progression, cardiac function, quality of life, and new cardiovascular complications. The study uses comprehensive imaging and clinical data to provide a scientific basis for improving clinical decision-making and patient care in valvular heart disease.

CONDITIONS

Brief Title

Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • Willing and able to provide informed consent
  • Diagnosed with heart valve disease meeting one or more of these criteria:
    • Grade II or higher aortic valve regurgitation with specific echocardiographic measurements
    • Moderate or higher aortic valve stenosis based on velocity, gradient, or valve area
    • Grade II or higher mitral valve regurgitation with defined jet width or volume
    • Moderate or higher valve stenosis with valve area or mean gradient thresholds
    • Grade II or higher tricuspid valve regurgitation with defined jet width or volume
    • Significant tricuspid valve stenosis with pressure gradient or valve area criteria
    • Grade II or higher pulmonary valve regurgitation with jet width or volume measures
    • Moderate or higher pulmonary valve stenosis with pressure gradient or valve area limits
Not Eligible

You will not qualify if you...

  • Unwilling to accept registration and follow-up
  • Unable to cooperate with data collection and follow-up due to mental illness or other conditions
  • Life expectancy less than 12 months due to non-cardiac diseases such as cancer, liver disease, kidney disease, or end-stage lung disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants undergo annual outpatient follow-up visits including electrocardiography, echocardiography, blood analysis, and contrast-enhanced CT scans to monitor disease progression and outcomes.

Annual outpatient visits

Trial Site Locations

Total: 15 locations

1

Fujian Provincial Hospital, Affiliated to Fuzhou University

Fuzhou, Fujian, China

Actively Recruiting

2

Renmin Hospital of Wuhan University

Wuhan, Hubei, China, 430060

Actively Recruiting

3

Xiangya Hospital of Central South University

Changsha, Hunan, China, 410008

Actively Recruiting

4

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Actively Recruiting

5

The General Hospital of Northern Theater Command

Shenyang, Liaoning, China, 110031

Actively Recruiting

6

The First Affiliated Hospital of Air Force Medicial University

Xi'an, Shaanxi, China, 710032

Actively Recruiting

7

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China, 266000

Actively Recruiting

8

Huaxi Hospital

Chengdu, Sichuan, China

Actively Recruiting

9

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China, 830000

Actively Recruiting

10

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, China, 650032

Actively Recruiting

11

Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

12

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, China

Actively Recruiting

13

Navy General Hospital, Beijing

Beijing, China

Actively Recruiting

14

Army Medical Center of PLA

Chongqing, China, 400010

Actively Recruiting

15

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China, 200080

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

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.

Emmanuel Lansac, Kevin M Veen, Andria Joseph...

https://pubmed.ncbi.nlm.nih.gov/39966045