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

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ClinicalTrials.gov Identifier: NCT04780607
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Xu Meng, Beijing Anzhen Hospital

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.

Condition or disease Intervention/treatment
Outcomes of Mitral Valve Surgery in Patients Affected by Rheumatic Heart Disease Device: mitral valve repair

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Multicenter Results of Mitral Valve Surgery in Patients With Rheumatic Heart Disease
Actual Study Start Date : January 1, 2011
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases


Intervention Details:
  • Device: mitral valve repair
    different repair techniques to construct rheumatic mitral valve lesion


Primary Outcome Measures :
  1. all-cause mortality [ Time Frame: 2011-2024 ]
    death from any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  1. patients with rheumatic heart disease
  2. mitral valve disease
  3. patients underwent initial mitral valve surgery or intervention
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780607


Contacts
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Contact: xu meng, MD mengxu191116@163.com
Contact: jintao fu, MD, postdoctor doctorfu0709@126.com

Locations
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China, Beijing
Beijing Anzhen Hospital Recruiting
Beijing, Beijing, China, 100086
Contact: xu meng, MD       mengxu191116@163.com   
Sponsors and Collaborators
Beijing Anzhen Hospital
Investigators
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Principal Investigator: xu meng, MD Beijing Anzhen Hospital
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Responsible Party: Xu Meng, NO.9 department of Cardiac surgery center, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT04780607    
Other Study ID Numbers: MARS
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Xu Meng, Beijing Anzhen Hospital:
rheumtic heart disease
mitral valve surgery
Additional relevant MeSH terms:
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Rheumatic Heart Disease
Rheumatic Diseases
Heart Diseases
Cardiovascular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Rheumatic Fever
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections