Treatment of Moderate FMR During AVR

September 30, 2022 updated by: Fuwai Yunnan Cardiovascular Hospital

Surgical Treatment of Aortic Valve Disease With Moderate Functional Mitral Regurgitation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

154

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuwai Yunnan Cardiovascular Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2022

Primary Completion (ANTICIPATED)

October 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

September 30, 2022

First Submitted That Met QC Criteria

September 30, 2022

First Posted (ACTUAL)

October 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FZX2019-06-01 2022YFKY088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Functional Mitral Regurgitation

Clinical Trials on mitral valve repair

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe