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Study on Standard Evaluation System and Optimal Treatment Path of Senile Valvular Heart Disease

China Degenerative Valve Disease II Cohort Study (China-DVD2 Study)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05044338
Enrollment
6000
Registered
2021-09-14
Start date
2021-09-01
Completion date
2023-11-30
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular Heart Disease

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

Interventions

DIAGNOSTIC_TESTimaging

(1) Build the first full information big data cloud platform for diagnosis, treatment and clinical research of senile valvular disease in China (2) To establish a cohort of elderly patients with valvular disease in China and a complete database covering clinical information, functional, imaging evaluation, treatment and follow-up; (3) To analyze the clinical characteristics, functional status and imaging characteristics of senile valvular disease in China, and to understand the current situation of diagnosis and treatment; To establish a whole process standardized comprehensive evaluation system of clinical indicators of senile valvular disease combined with a variety of imaging for Chinese people.

Sponsors

Yongjian Wu
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
all-cause mortalityTime Frame: 2yearsall-cause mortality

Countries

China

Contacts

Primary Contacthaiyan xu, doctor
xuhaiyan@fuwaihospital.org+86 13681012249

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026