Treatment of Moderate FMR During AVR | NCT05566340

Studies
Treatment of Moderate FMR During AVR

NCT05566340

Sponsor

Fuwai Yunnan Cardiovascular Hospital

Status

Unknown status

Last Update Posted

Oct 4, 2022Actual

Enrollment

154Estimated

Phase

Not provided

Conditions

Functional Mitral Regurgitation

Interventions

mitral valve repair

Countries

Not provided

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

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2022Estimated

Primary Completion Date

Oct 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Sep 30, 2022

First Submission Date that Met QC Criteria

Sep 30, 2022

First Posted Date

Oct 4, 2022Actual

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

Sep 30, 2022

Last Update Posted Date

Oct 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Debates exist on the treatment of moderate functional mitral regurgitation (FMR) in patients undergoing aortic valve replacement (AVR) for aortic valve disease. This study aims to evaluate the left ventricular function, which was evaluated through global longitudinal strain, after isolated AVR and AVR + mitral valve repair (MVr) in this group of patients.

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

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

154Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
isolated aortic valve replacement group		Isolated aortic valve replacement surgery.	Procedure: mitral valve repair
aortic valve replacement with mitral valve repair group		Aortic valve replacement with mitral valve repair	Procedure: mitral valve repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mitral valve repair	Procedure	Repair of mitral valve concomitant to aortic valve replacement.	aortic valve replacement with mitral valve repair group isolated aortic valve replacement group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
left ventricular global longitudinal strain	The change of left ventricular global longitudinal strain compared to before surgery	10/10/2022-10/10/2023

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who received AVR (with or without concomitant MVr) from two center (Fuwai Yunnan Cardiovascular Hospital and Fuwai Hospital, Chinese Academy of Medical Sciences).
Age more than 18 years.

Exclusion Criteria:

Those with a history of rheumatic valvular disease or infective endocarditis.
Primary mitral valve lesions.
Patients receiving mitral valve replacement.
Patient who refuse to participate in this study, or cannot complete 6-month follow-up after surgery.
Age < 18 years.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A total of 154 patients with moderate FMR undergoing isolated AVR or AVR + MVr will be prospectively enrolled.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xieraili Tiemuerniyazi	Contact	+86-18814115887		tiemuernyz@mail2.sysu.edu.cn

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

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

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Browse Branches

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