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NCT Number: NCT06741709

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

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.

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Key information

Age range

18 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Kerolos R. Ayad, MA

CONTACT

[email protected]

+2 01272872479

Yousra M. Hamdy, Lecturer

CONTACT

[email protected]

+2 01003314748

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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