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Recruiting NCT07436962

Loop Recorder Implantation in Patients With Mitral Annular Disjunction

Trial Parameters

Condition Mitral Annular Disjunction
Sponsor Gottsegen National Cardiovascular Institute
Study Type INTERVENTIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2025-12-05
Completion 2028-02
Interventions
loop recorder implantation

Brief Summary

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.

Eligibility 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

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