Outcomes of Mitral Valve Surgery in Patients Affected by... | NCT04780607

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

NCT04780607

Sponsor

Beijing Anzhen Hospital

Status

Unknown status

Last Update Posted

Mar 3, 2021Actual

Enrollment

4,000Estimated

Phase

Not provided

Conditions

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

Interventions

mitral valve repair

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Jan 1, 2024Estimated

Completion Date

Apr 1, 2024Estimated

First Submitted Date

Mar 1, 2021

First Submission Date that Met QC Criteria

Mar 1, 2021

First Posted Date

Mar 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2021

Last Update Posted Date

Mar 3, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xu Meng, NO.9 department of Cardiac surgery center, Beijing Anzhen HospitalPrincipal Investigator

Lead Sponsor

Beijing Anzhen HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mitral valve repair	Device	different repair techniques to construct rheumatic mitral valve lesion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all-cause mortality	death from any cause	2011-2024

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with rheumatic heart disease
mitral valve disease
patients underwent initial mitral valve surgery or intervention

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xu meng, MD	Contact			mengxu191116@163.com
jintao fu, MD, postdoctor	Contact			doctorfu0709@126.com

Overall Officials

Name	Affiliation	Role
xu meng, MD	Beijing Anzhen Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Anzhen Hospital	Recruiting	Beijing	Beijing Municipality	100086	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058386	Mitral Valve Annuloplasty

Ancestor Terms

ID	Term
D058385	Cardiac Valve Annuloplasty
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided