NCT05044338UnknownNot Applicable
China Degenerative Valve Disease II Cohort Study (China-DVD2 Study)
Yongjian Wu1 site in 1 country6,000 target enrollmentStarted: September 1, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 6,000
- Locations
- 1
- Primary Endpoint
- all-cause mortality
Study Overview
Brief Summary
The key technology research and standard evaluation system of elderly heart valve disease evaluation is to further establish a domestic multi center and large sample full information big data platform of elderly heart valve disease based on the previous Chinese elderly valve disease cohort and clinical research platform and the national valve disease surgery data platform.
Detailed Description
Establish clinical and Imaging Database
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with heart valve disease who are ≥ 65 years old and diagnosed by echocardiography meet the requirements
- •One of the following criteria:
- •(1)Severe mitral stenosis: valve orifice area < 1.0cm2;
- •(2)Severe mitral regurgitation: constriction neck width ≥ 7mm, or regurgitation per beat (regurgitation volume)≥ 60ml, or reflux beam area / left atrial area > 50%; Or effective reflux port area (eroa) ≥ 0.4cm2;
- •(3)Severe aortic stenosis: mean cross valve pressure difference ≥ 40mmhg, or maximum jet velocity ≥ 4m / s, orValve orifice area < 1.0cm2, it should be differentiated from left ventricular outflow tract stenosis;
- •(4)Severe aortic regurgitation: constriction neck width > 6mm, or each pulsation regurgitation ≥ 60ml, or regurgitation Flow fraction ≥ 50%, or jet width ≥ 65% of left ventricular outflow tract, or effective reflux orifice area (eroa) ≥0.3cm2；
- •(5)Severe tricuspid stenosis: mean cross valve pressure difference ≥ 5mmhg;
- •(6)Severe tricuspid regurgitation: constriction neck width ≥ 7mm, or effective regurgitation orifice area (eroa)≥0.4cm2；
- •(7)Severe pulmonary stenosis: the forward blood flow velocity is ≥ 4m / s, which should be differentiated from right ventricular outflow tract stenosis; Severe pulmonary valve regurgitation: massive regurgitation, wide constriction neck
Exclusion Criteria
- •Patients unwilling to accept registration and follow-up;
- •Patients with mental illness who cannot cooperate with information collection and follow-up
Outcomes
Primary Outcomes
all-cause mortality
Time Frame: Time Frame: 2years
all-cause mortality
Secondary Outcomes
No secondary outcomes reported
Investigators
Yongjian Wu
Chief physician
China National Center for Cardiovascular Diseases
Study Sites (1)
Loading locations...
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