Loop recorder placement for people with mitral annular disjunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective single-center interventional study will implant up to 20 BioMonitor IIIm implantable loop recorders (ILRs) in patients aged 18–60 with echocardiography-confirmed mitral annular disjunction and late gadolinium enhancement on cardiac MRI but no guideline indication for an ICD or ILR. The ILRs will continuously record heart rhythms to detect asymptomatic or symptomatic ventricular arrhythmias over scheduled follow-up. The protocol targets patients with mild or uncertain symptoms such as palpitations or dizziness to confirm or exclude arrhythmic causes. Key exclusions include active infection, cancer, prior ICD implantation, or any existing indication for ICD/ILR according to current recommendations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* age between 18 and 60 years
* patient not incapacitated
* mitral annular disjunction confirmed by echocardiography
* MR scan confirmed late-type gadolinium enhancement in the myocardium

Exclusion Criteria:

* lack of informed consent
* age under 18 years
* limited capability
* guardianship
* active infection
* cancer
* previous ICD implantation
* indication for ICD or ILR implantation based on current recommendation

Where it's running

• Gottsegen National Cardiovascular Institute
  Budapest, Hungary Recruiting

Study contacts

• Principal investigator: Attila Kardos, MD PhD — Gottsegen National Cardiovascular Institute
• Study coordinator: Attila Kardos, MD PhD
• Email: attila.kardos@gokvi.hu
• Phone: +36703388864

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.