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

• Conditions: Valvular Heart Disease

• Registration Number: NCT05044338
• Lead Sponsor: Yongjian Wu

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 Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-01
• Study First Submitted: 2021-09-12
• Study First Submitted QC: 2021-09-12
• Study First Posted: 2021-09-14
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-16
• Primary Completion: 2023-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all-cause mortality	Time Frame: 2years	all-cause mortality

Trial Locations

Locations (1)

Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China