RecruitingNCT07267117

Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

10,000 participants

Start Date

Jun 1, 2025

Study Type

OBSERVATIONAL

Conditions

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. Additionally, the study aims to analyze the potential impact of device-based interventions, pharmacological therapy, and lifestyle modifications on disease progression.


Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • 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.
  • 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.

Exclusion Criteria3

  • 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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Locations(15)

Fujian Provincial Hospital, Affiliated to Fuzhou University

Fuzhou, Fujian, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

The General Hospital of Northern Theater Command

Shenyang, Liaoning, China

The First Affiliated Hospital of Air Force Medicial University

Xi'an, Shaanxi, China

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Huaxi Hospital

Chengdu, Sichuan, China

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, China

Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Chinese Academy of Medical Sciences, Fuwai Hospital

Beijing, China

Navy General Hospital, Beijing

Beijing, China

Army Medical Center of PLA

Chongqing, China

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

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NCT07267117


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