A Study of Mitral Annular Disjunction in Mitral Valve Prolapse Patients and Arrhythmia Risk

December 15, 2024 updated by: Kerolos Rezk Ayad Girgis, Assiut University
This study investigates the characteristics and prevalence of mitral annular disjunction in patients with mitral valve prolapse with severe mitral regurgitation (MR) at Assiut University Heart Hospital.

Study Overview

Status

Not yet recruiting

Detailed Description

Mitral annular disjunction is a structural defect of the mitral annulus fibrous commonly associated with mitral leaflet prolapse. However, there have been few cases of mitral annular disjunction in mitral valve prolapse (MVP).

Mitral annular disjunction (MAD) is a structural defect characterized by a clear separation between the mitral valve annulus, the left atrium wall, and the myocardial continuity. This condition can be seen in a 360-degree circle around the mitral valve annulus. However, it is most typically seen in the inferolateral myocardium, right behind the posterior mitral valve leaflet. It is generally present in the P1 and P2 mitral valve scallops.

Mitral valve prolapse (MVP) occurs in 3% of the population and is the most common reason for mitral valve replacement[1]. According to population and cohort studies, the patient's age significantly influences mitral valve prolapse (MVP) outcomes, left ventricular ejection fraction, and the severity of mitral regurgitation. Mitral regurgitation has little influence if it is not severe. While the link between MVP and sudden cardiac death was first discovered many years ago, it was once assumed to be extremely low risk. Recent observational studies have found a link between MVP and malignant ventricular arrhythmias, as well as sudden cardiac death, in a particular population of young and middle-aged people. This raise worries regarding the existence of an arrhythmic MVP variation. Recent research has led to a better knowledge of the aberrant physiological processes and circumstances that enhance the likelihood of developing irregular heart rhythms in people with mitral valve prolapse.

The diagnosis of mitral valve regurgitation can be accurately determined by non-invasive imaging techniques such as transthoracic echocardiography, Transesophageal echocardiography, and cardiac magnetic resonance imaging.

This study tries to improve patient risk assessment

Study Type

Observational

Enrollment (Estimated)

30

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

Study Contact Backup

Study Locations

    • Asyut
      • Assiut, Asyut, Egypt, 71111
        • Assiut University
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

30

Description

Inclusion Criteria:

  • All consecutive patients > 18 years of age presenting to Assiut University Heart Hospital with MVP and more than moderate MR.

Exclusion Criteria:

  • Previous mitral valve surgery.

    • MVP due to infective endocarditis.
    • Moderate or more significant aortic stenosis, aortic regurgitation or mitral stenosis.
    • Congenital heart disease and poor image quality precluding accurate assessment of the mitral valve.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detect the prevalence of mitral annular disjunction in patients with mitral valve prolapse
Time Frame: six months
Detect the prevalence of mitral annular disjunction in patients with mitral valve prolapse
six months

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Estimated)

February 14, 2025

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

December 15, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 15, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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