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

Valvular Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05044338
• Other study ID #: 2020YFC2008100
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

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