Treatment of Moderate FMR During AVR

Sponsor

Fuwai Yunnan Cardiovascular Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05566340

Collaborator

(none)

154

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Functional Mitral Regurgitation	Procedure: mitral valve repair

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

154 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Surgical Treatment of Aortic Valve Disease With Moderate Functional Mitral Regurgitation

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
isolated aortic valve replacement group Isolated aortic valve replacement surgery.	Procedure: mitral valve repair Repair of mitral valve concomitant to aortic valve replacement.
aortic valve replacement with mitral valve repair group Aortic valve replacement with mitral valve repair	Procedure: mitral valve repair Repair of mitral valve concomitant to aortic valve replacement.

Arm

Intervention/Treatment

isolated aortic valve replacement group

Isolated aortic valve replacement surgery.

Procedure: mitral valve repair

Repair of mitral valve concomitant to aortic valve replacement.

aortic valve replacement with mitral valve repair group

Aortic valve replacement with mitral valve repair

Procedure: mitral valve repair

Repair of mitral valve concomitant to aortic valve replacement.

Outcome Measures

Primary Outcome Measures

left ventricular global longitudinal strain [10/10/2022-10/10/2023]
The change of left ventricular global longitudinal strain compared to before surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fuwai Yunnan Cardiovascular Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fuwai Yunnan Cardiovascular Hospital

ClinicalTrials.gov Identifier:

NCT05566340

Other Study ID Numbers:

FZX2019-06-01 2022YFKY088

First Posted:

Oct 4, 2022

Last Update Posted:

Oct 4, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fuwai Yunnan Cardiovascular Hospital

functional mitral regurgitation

aortic valve replacement

mitral valve repair

Additional relevant MeSH terms:

Mitral Valve Insufficiency

Study Results

No Results Posted as of Oct 4, 2022