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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05044338
Other study ID # 2020YFC2008100
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date November 2023

Study information

Verified date September 2021
Source China National Center for Cardiovascular Diseases
Contact haiyan xu, doctor
Phone +86 13681012249
Email xuhaiyan@fuwaihospital.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Establish clinical and Imaging Database


Recruitment information / eligibility

Status Recruiting
Enrollment 6000
Est. completion date November 2023
Est. primary completion date November 2023
Accepts healthy volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
imaging
(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.

Locations

Country Name City State
China Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Yongjian Wu

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary all-cause mortality all-cause mortality Time Frame: 2years
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