Loop Recorder Implantation in Patients With Mitral Annular Disjunction

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.

NCT Number	NCT07436962
Lead Sponsor	Gottsegen National Cardiovascular Institute Collaborators: Biotronik SE & Co. KG
Conditions	Mitral Annular Disjunction, Mitral Valve, Arrhythmia Ventricular, Sudden Cardiac Death Due to Cardiac Arrhythmia, Loop Recorder
Enrollment	20 participants
Start Date	2025-12-05
Primary Completion	2028-02 (estimated)
Study Completion	2030-02 (estimated)
Updated on ClinicalTrials.gov	2026-03-02