RecruitingNot Applicable

Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease

China10,000 participantsStarted 2025-06-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.

What they're measuring

All cause mortality

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

Heart valve replacement or repair

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

Stroke

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

Re-hospitalization related to cardiovascular disease

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

Trial details

NCT IDNCT07267117

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Heart Valve Disease trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.