Treatment of Moderate FMR During AVR

NCT05566340 | Unknown

• 1 other identifier: FZX2019-06-01 2022YFKY088
• Study Type: observational
• Target: 154
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Functional Mitral Regurgitation

Keywords

functional mitral regurgitation; aortic valve replacement; mitral valve repair

Outcome Measures

Primary Outcomes (1)

• left ventricular global longitudinal strain

  The change of left ventricular global longitudinal strain compared to before surgery

  10/10/2022-10/10/2023

Study Arms (2)

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fuwai Yunnan Cardiovascular Hospital: lead

MeSH Terms

Interventions

Mitral Valve Annuloplasty

Intervention Hierarchy (Ancestors)

Cardiac Valve Annuloplasty; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Central Study Contacts

Xieraili Tiemuerniyazi

CONTACT

+86-18814115887; tiemuernyz@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 4, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share