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

NCT07816146 | Not Yet Recruiting DMC

• 1 other identifier: 2025-ZX223/2026-GPS-GG-24
• Study Type: observational
• Target: 6,612
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Valve Diseases; Moderate to Severe Valve Disease in the Elderly

Keywords

Heart Valve Diseases; Valvular Heart Diseases; Senile valve disease

Outcome Measures

Primary Outcomes (1)

• First valve intervention during this hospitalization

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

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (1)

• 1、Repeat valve intervention 2、Cardiovascular adverse events

  From enrollment to the 12-month follow-up endpoint

Study Arms (1)

China elderly Valve Disease Study III (China-DVD3 study)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This project is scheduled to be implemented from September to December 2026. It will consecutively enroll hospitalized patients with moderate and severe valvular heart disease across the original 69 national research centers of China-DVD, with the research protocol and definitions fully consistent with those in 2016.

You may qualify if:

• Hospitalized patients over 60 years old meet one of the following conditions.
• 、 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yongjian Wu, MD, PhD: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• yongjian wu, doctor

  Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Haiyan Xu, Doctor

CONTACT

+86 13681012249; xuhaiyan@fuwaihospital.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Coronary Heart Disease Center

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: September 7, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)