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Clinical Trials in China / NCT07267117
Recruiting Observational

Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease

NCT07267117 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Observational
Started
2025-06-01
Last updated
2025-12-05

Condition(s) studied

Heart Valve DiseaseMitral Valve (MV) RegurgitationMitral Valve DiseaseMitral Valve StenosisAortic Valve DiseaseAortic Valve StenosisTricuspid Valve DiseaseTricuspid Valve RegurgitationAortic Valve RegurgitationPulmonary Valve DiseaseTranscatheter Valve ReplacementTranscatheter Aortic Valve Replacement (TAVR)Transcatheter Pulmonary Valve Replacement (TPVR)Transcatheter Edge-to-edge Repair

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Fujian Provincial Hospital, Affiliated to Fuzhou University Fuzhou Fujian Recruiting
Renmin Hospital of Wuhan University Wuhan Hubei Recruiting
Xiangya Hospital of Central South University Changsha Hunan Recruiting
Second Xiangya Hospital of Central South University Changsha Hunan Recruiting
The General Hospital of Northern Theater Command Shenyang Liaoning Recruiting
The First Affiliated Hospital of Air Force Medicial University Xi'an Shaanxi Recruiting
Affiliated Hospital of Qingdao University Qingdao Shandong Recruiting
Huaxi Hospital Chengdu Sichuan Recruiting
People's Hospital of Xinjiang Uygur Autonomous Region Ürümqi Xinjiang Recruiting
Fuwai Yunnan Cardiovascular Hospital Kunming Yunnan Recruiting
Second Affiliated Hospital of Zhejiang University, School of Medicine Hangzhou Zhejiang Recruiting
Chinese Academy of Medical Sciences, Fuwai Hospital Beijing China Recruiting
Navy General Hospital, Beijing Beijing China Recruiting
Army Medical Center of PLA Chongqing China Recruiting
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China Recruiting

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07267117 on ClinicalTrials.gov ↗ ← All trials in China