NCT04780607

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

March 3, 2021

Status Verified

January 1, 2021

Enrollment Period

13 years

First QC Date

March 1, 2021

Last Update Submit

March 1, 2021

Conditions

Outcomes of Mitral Valve Surgery in Patients Affected by Rheumatic Heart Disease

Keywords

rheumtic heart diseasemitral valve surgery

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality

    death from any cause

    2011-2024

Interventions

mitral valve repairDEVICE

different repair techniques to construct rheumatic mitral valve lesion

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1. patients with rheumatic heart disease 2. mitral valve disease 3. patients underwent initial mitral valve surgery or intervention

You may qualify if:

  • 、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

You may not qualify if:

  • 、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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100086, China

RECRUITING

MeSH Terms

Interventions

Mitral Valve Annuloplasty

Intervention Hierarchy (Ancestors)

Cardiac Valve AnnuloplastyCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • xu meng, MD

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xu meng, MD

CONTACT

mengxu191116@163.com

jintao fu, MD, postdoctor

CONTACT

doctorfu0709@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
NO.9 department of Cardiac surgery center

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 3, 2021

Study Start

January 1, 2011

Primary Completion

January 1, 2024

Study Completion

April 1, 2024

Last Updated

March 3, 2021

Record last verified: 2021-01

Locations

CN(1)