Loop Recorder Implantation in Patients With Mitral Annular Disjunction

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.

Conditions

• Mitral Annular Disjunction
• Mitral Valve
• Arrhythmia Ventricular
• Sudden Cardiac Death Due to Cardiac Arrhythmia
• Loop Recorder

Interventions

DEVICE

loop recorder implantation

During the operation, a small incision is made in the chest with local anesthesia and the implantation is performed in a pacemaker operating room, following the rules of sepsis/antisepsis. The surgical suture is used to close the wound. The healing time is about 10 days, during which time a covering bandage is needed. During the operation we use absorbable sutures, no suture removal is necessary. After implantation, the patient's lifestyle is not restricted. Avoidance of strong magnetic fields, which may result in noise recording, is necessary. The procedure is performed as an outpatient surgery and patients are discharged to their homes on the day of the procedure.

Sponsors & Collaborators

• Biotronik SE & Co. KG

  collaborator INDUSTRY

• Gottsegen National Cardiovascular Institute

  lead OTHER

Principal Investigators

• Attila Kardos, MD PhD · Gottsegen National Cardiovascular Institute

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-05

Primary Completion

2028-02-29

Completion

2030-02-28

Countries

• Hungary

Study Locations