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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04780607
Other study ID # MARS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date April 1, 2024

Study information

Verified date January 2021
Source Beijing Anzhen Hospital
Contact xu meng, MD
Email mengxu191116@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

rheumatic heart disease remains the majority valvular disease in low and middle income countries, which mostly affected mitral valve, surgical treatment is the most effective strategy to improve the outcomes of middle or late-stage RHD patient, however, whether mitral valve repair surgery is superior to replacement or other evolving interventional device remains controversial, this study aims to investigate the results of repair surgery compared with replacement or other treatment strategy from international multicenters.


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
Est. completion date April 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 1?rheumatic heart disease 2?mitral valve disease 3?combined with other heart valve disease(aortic valve, tricuspid valve, pulmonary valve) 4?patients underwent initial mitral valve surgery or intervention Exclusion Criteria: - 1?congenital heart disease degenerative heart valve disease 2?isolated aortic valve or tricuspid valve, pulmonary valve disease( doesn't affect mitral valve ) 3?patients received more than 1 time mitral valve operation

Study Design


Related Conditions & MeSH terms


Intervention

Device:
mitral valve repair
different repair techniques to construct rheumatic mitral valve lesion

Locations

Country Name City State
China Beijing Anzhen Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary all-cause mortality death from any cause 2011-2024