China Elderly Valve Disease Study III (China-DVD3 Study)

N/ANot Yet RecruitingNCT07816146

Yongjian Wu, MD, PhD6,612 enrolled

Overview

This study aims to conduct a second round of multicenter, prospective registry research targeting elderly patients with valvular heart disease, to understand the current status of interventions for patients with valvular heart disease. To systematically evaluate the distribution of types, clinical characteristics, interventions, and complications of elderly valvular heart disease, and to compare and analyze these with the China-DVD data from 2016, thereby revealing its evolutionary trends. By comprehensively considering various clinical characteristics such as different types of valvular lesions, treatment modalities, patient cardiac function, comorbidities, and blood test indicators, as well as multidimensional factors including psychological and lifestyle aspects, to deeply identify the key determinants influencing the treatment of elderly valvular heart disease patients in China, and thus optimize and improve their individualized comprehensive management pathways.

Study Type

OBSERVATIONAL

Enrollment

6,612

Conditions

Heart Valve Diseases Moderate to Severe Valve Disease in the Elderly

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: Hospitalized patients over 60 years old meet one of the following conditions. 1、 moderate or above valvular heart disease as defined by echocardiography: One of the following criteria * (1)Mitral stenosis : Valve area ≤1.5 cm², or mean pressure gradient ≥10 mmHg. * (2)Mitral regurgitation : Moderate and above regurgitation, or regurgitant jet width ≥ 3 mm, or regurgitant volume per beat ≥ 30 ml, or regurgitant jet area/left atrial area \> 20%; or effective regurgitant orifice area (EROA) ≥ 20 mm² * (3)Aortic stenosis : Moderate and above, mean pressure gradient ≥ 20 mmHg, or peak jet velocity ≥ 3 m/s, or valve area ≤ 1.5 cm² * (4)Aortic regurgitation : Moderate and above regurgitation, or regurgitant jet width ≥ 3 mm, or regurgitant volume per beat ≥ 30 ml, or regurgitant fraction ≥ 30%, or jet width occupying ≥ 25% of the left ventricular outflow tract, or effective regurgitant orifice area (EROA) ≥ 10 mm² * (5)Tricuspid stenosis : Moderate and above * (6)Tricuspid regurgitation : Moderate and above regurgitation, or jet area ≥ 5 cm² * (7)Pulmonary stenosis : Moderate and above * (8）Pulmonary regurgitation : Moderate and above regurgitation 2 、Previous history of cardiac valve surgery or interventional therapy (dilation, valvuloplasty, valve replacement) 3、Diagnosed with infective endocarditis Exclusion Criteria: Patients unwilling to accept registration and follow-up; * Patients with mental illness who cannot cooperate with information collection and follow-up Patients have been enrolled in this study.

Outcomes

Primary Outcomes

First valve intervention during this hospitalization

Underwent their first internal medicine intervention or surgical procedure during hospitalization for valvular heart disease in this study

Time frame: From enrollment to the end of treatment at 12 weeks

Secondary Outcomes

1、Repeat valve intervention 2、Cardiovascular adverse events

1 、Repeat valve intervention : After the first valve intervention, the patient receives another valve surgical or interventional procedure due to valvular-related causes. 2、Cardiovascular adverse events : Any new-onset or recurrent cardiovascular disease, rehospitalization for cardiovascular reasons, and cardiac death, etc.

Time frame: From enrollment to the 12-month follow-up endpoint