Loop recorder placement for people with mitral annular disjunction
Loop Recorder Implantation in Patients With Mitral Annular Disjunction
This project will try implanting small loop recorders in adults 18–60 with mitral annular disjunction and MRI scarring to see if they have hidden ventricular arrhythmias.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Gottsegen National Cardiovascular Institute Academic / other |
| Locations | 1 site (Budapest) |
| Trial ID | NCT07436962 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–60 with echocardiography-confirmed mitral annular disjunction, late gadolinium enhancement on cardiac MRI, mild or uncertain symptoms, and no current guideline indication for ICD or ILR are ideal candidates.
Not a fit: Patients who already meet criteria for ICD/ILR, those under 18 or over 60, or those with active infection, cancer, limited capacity, guardianship, or prior ICD implantation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, routine ILR monitoring could uncover otherwise missed ventricular arrhythmias and help guide timely treatment to reduce the risk of sudden cardiac death.
How similar studies have performed: Small observational series and device registries show ILRs can detect arrhythmias and case reports link mitral annular disjunction to ventricular arrhythmias, but prospective data in this specific population are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Budapest
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.