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Not yet recruitingNCT06741709Updated Dec 19, 2024

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

An observational study in Mitral Valve Prolapse and Mitral Valve Insufficiency, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Months and older. Per ClinicalTrials.gov, last updated 2024-12-19.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Months and older
Sex
All
01

Study summary

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.

Read the 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

02

Conditions studied

  • Mitral Valve Prolapse
  • Mitral Valve Insufficiency

Keywords

  • Mitral annular disjunction
03

In context

Mitral Valve Prolapse

47 studies on the registry are indexed under Mitral Valve Prolapse; 11 are open to participants now.

This study's planned enrollment of 30 is below the median of 150 across 25 observational studies indexed under Mitral Valve Prolapse.

Browse Mitral Valve Prolapse studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

30

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Detect the prevalence of mitral annular disjunction in patients with mitral valve prolapse

    Detect the prevalence of mitral annular disjunction in patients with mitral valve prolapse

    Time frame: six months

07

Study locations

1 site
08

References and documents

Publications

  • Hussain N, Bhagia G, Doyle M, Rayarao G, Williams RB, Biederman RWW. Mitral annular disjunction; how accurate are we? A cardiovascular MRI study defining risk. Int J Cardiol Heart Vasc. 2023 Nov 9;49:101298. doi: 10.1016/j.ijcha.2023.101298. eCollection 2023 Dec. PubMed 38035256 ↗
  • Tison GH, Abreau S, Barrios J, Lim LJ, Yang M, Crudo V, Shah DJ, Nguyen T, Hu G, Dixit S, Nah G, Arya F, Bibby D, Lee Y, Delling FN. Identifying Mitral Valve Prolapse at Risk for Arrhythmias and Fibrosis From Electrocardiograms Using Deep Learning. JACC Adv. 2023 Aug;2(6):100446. doi: 10.1016/j.jacadv.2023.100446. Epub 2023 Aug 5. PubMed 37936601 ↗
  • Donal E, Galli E, Letourneau T. Need for expertise in mitral valve regurgitation. Open Heart. 2019 Apr 28;6(1):e001039. doi: 10.1136/openhrt-2019-001039. eCollection 2019. No abstract available. PubMed 31168391 ↗
  • Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available. PubMed 28314623 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2025; primary completion for Oct 2026, 20 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2024
First posted
Dec 19, 2024
StartEst.
Feb 14, 2025
Primary completionEst.
Oct 30, 2026
CompletionEst.
Dec 30, 2026
Last update
Dec 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06741709
Lead sponsor
Assiut University
Responsible party
Kerolos Rezk Ayad Girgis (Resident doctor, Assiut University) — Principal investigator
First posted
Dec 19, 2024
Start date
Feb 14, 2025 (estimated)
Primary completion
Oct 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Dec 19, 2024

Study contacts

Kerolos R. Ayad, MA
Contact
kerorezk37@gmail.com
+2 01272872479
Yousra M. Hamdy, Lecturer
Contact
Yousra.ghzally@med.aun.edu.eG
+2 01003314748

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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