Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT07436962

Loop Recorder Implantation in Patients With Mitral Annular Disjunction

Led by Gottsegen National Cardiovascular Institute · Updated on 2026-03-02

20

Participants Needed

1

Research Sites

217 weeks

Total Duration

On this page

Sponsors

G

Gottsegen National Cardiovascular Institute

Lead Sponsor

B

Biotronik SE & Co. KG

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of clinical trial is to prospectively collect data to investigate the prevalence of arrhythmia in young patients diagnosed with mitral annular disjunction who have no indication for implantable cardioverter defibrillator (ICD) or implantable loop recorder (ILR) implantation according to the current guideline. The study population is young (age 18-60), the participating patients have mitral annular disjunction confirmed by echocardiography and MR scan confirmed late-type gadolinium enhancement in the myocardium. This patient population has an increased risk of ventricular arrhythmias and sudden cardiac death. The investigators plan to implant 20 BioMonitor IIIm ILRs over a year in patients with mild or uncertain symptoms (dizziness, palpitations) and no malignant arrhythmias. Aims of the study: 1. Screening of asymptomatic patients with MAD for arrhythmia. 2. In case of symptoms, to prove or exclude the underlying arrhythmia. BioMonitor IIIm ILR implantation is planned in the following patient population: 1. Inclusion of 20 patients with mitral annular disjunction confirmed by echocardiography and late gadolinium enhancement in the myocardium by MRI. 2. Only patients who do not meet the current indication for ICD or ILR implantation based on the current recommendation will be included in the study.

CONDITIONS

Official Title

Loop Recorder Implantation in Patients With Mitral Annular Disjunction

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 60 years
  • Patient is not incapacitated
  • Mitral annular disjunction confirmed by echocardiography
  • Late-type gadolinium enhancement in the myocardium confirmed by MRI scan
Not Eligible

You will not qualify if you...

  • Lack of informed consent
  • Age under 18 years
  • Limited capability
  • Under guardianship
  • Active infection
  • Cancer
  • Previous ICD implantation
  • Indication for ICD or ILR implantation based on current guidelines

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Gottsegen National Cardiovascular Institute

Budapest, Hungary, 1096

Actively Recruiting

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Research Team

A

Attila Kardos, MD PhD

CONTACT

S

Sara Mladoniczky, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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