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A real world study of use of bioprosthetic heart valve for heart valve disease treatment in Chinese population

A real world study of use of bioprosthetic heart valve for heart valve disease treatment in Chinese population

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300071626
Enrollment
Unknown
Registered
2023-05-19
Start date
2022-12-15
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HEART VALVE DISEASE

Interventions

Artificial biological heart valve treatment group:N/A

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age at valve implantation =70 years old; 2. Patients who underwent cardiac valve replacement for the first time (including aortic valve, mitral valve, and combined replacement, etc.) between May 1, 2019 and December 31, 2021; 3.The patients or their guardians (proxies) were informed of the nature of the trial and agreed to all the terms of participation in the trial, and they voluntarily signed an informed consent form that was approved by the ethics committee.

Exclusion criteria

Exclusion criteria: 1. Transcatheter valve implantation; 2. Patients with past or present mental illness; 3. Refusal to participate in the study; 4. Severe hearing or language disorders and communication disorders; 5. Other conditions considered by the investigator to be inappropriate for enrollment

Design outcomes

Primary

MeasureTime frame
The 1-year all-cause mortality and major composite cardiovascular and cerebrovascular events (MACCEs) (defined as acute myocardial infarction, stroke (ischemia and bleeding), and rehospitalization for heart failure) were recorded;

Secondary

MeasureTime frame
Early mortality: within 30 days or perioperative or in-hospital death;Valve performance was evaluated, including mean transvalvular pressure gradient, effective valve orifice area, and degree of prosthetic valve regurgitation;Incidence of valve-related complications: including valve thrombosis, paravalvular leak and prosthetic valve failure, myocardial infarction, conduction block, rehospitalization for heart failure, infective endocarditis (inflammation of the heart membrane directly caused by bacterial, fungal, or viral infection).;Valve reintervention: Any valve-related reoperation to repair, alter, adjust, or replace a previously implanted valve.;Major bleeding events included retinal and choroidal hemorrhage, joint hemorrhage, epistaxis, hemoptysis, gastrointestinal hemorrhage, pericardial hemorrhage, and intracerebral hemorrhage;Cardiac function classification (NYHA);Overall survival (person/year);Quality of life assessment (KCCQ, EQ-5D, activities of daily living assessment);

Countries

CHINA

Contacts

Public ContactLIU LI MING

The Second Xiangya Hospital of Central South University

liulimingjia@aliyun.com+86 138 0748 9183

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026