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NCT05566340 Clinical Trial

Treatment of Moderate FMR During AVR

Functional Mitral Regurgitation Clinical Trial

Official title:
Surgical Treatment of Aortic Valve Disease With Moderate Functional Mitral Regurgitation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05566340
Other study ID # FZX2019-06-01 2022YFKY088
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2022
Est. completion date December 2023

Study information
Verified date September 2022
Source Fuwai Yunnan Cardiovascular Hospital
Contact Xieraili Tiemuerniyazi
Phone +86-18814115887
Email tiemuernyz@mail2.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 154
Est. completion date December 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients who received AVR (with or without concomitant MVr) from two center (Fuwai Yunnan Cardiovascular Hospital and Fuwai Hospital, Chinese Academy of Medical Sciences). 2. Age more than 18 years. Exclusion Criteria: 1. Those with a history of rheumatic valvular disease or infective endocarditis. 2. Primary mitral valve lesions. 3. Patients receiving mitral valve replacement. 4. Patient who refuse to participate in this study, or cannot complete 6-month follow-up after surgery. 5. Age < 18 years.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• mitral valve repair
Repair of mitral valve concomitant to aortic valve replacement.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fuwai Yunnan Cardiovascular Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary left ventricular global longitudinal strain The change of left ventricular global longitudinal strain compared to before surgery 10/10/2022-10/10/2023
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