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

Status: Recruiting
Location: See all (15) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Chinese Academy of Medical Sciences, Fuwai Hospital
RECRUITING
Beijing
Navy General Hospital, Beijing
RECRUITING
Beijing
Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Xiangya Hospital of Central South University
RECRUITING
Changsha
Huaxi Hospital
RECRUITING
Chengdu
Army Medical Center of PLA
RECRUITING
Chongqing
Fujian Provincial Hospital, Affiliated to Fuzhou University
RECRUITING
Fuzhou
Second Affiliated Hospital of Zhejiang University, School of Medicine
RECRUITING
Hangzhou
Fuwai Yunnan Cardiovascular Hospital
RECRUITING
Kunming
Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
The General Hospital of Northern Theater Command
RECRUITING
Shenyang
People's Hospital of Xinjiang Uygur Autonomous Region
RECRUITING
Ürümqi
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
The First Affiliated Hospital of Air Force Medicial University
RECRUITING
Xi'an
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2030-05-31
Participants
Target number of participants: 10000
Sponsors
Collaborators: Fujian Provincial Hospital, The First Affiliated Hospital of Air Force Medicial University, Fuwai Yunnan Cardiovascular Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Army Medical Center of PLA, The General Hospital of Northern Theater Command, The Affiliated Hospital of Qingdao University, Second Xiangya Hospital of Central South University, Xiangya Hospital of Central South University, Chinese Academy of Medical Sciences, Fuwai Hospital, Renmin Hospital of Wuhan University, Navy General Hospital, Beijing, Huaxi Hospital, People's Hospital of Xinjiang Uygur Autonomous Region
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov

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