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NCT Number: NCT07436962

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.

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Key information

Conditions

Mitral Annular Disjunction Arrhythmia Ventricular Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Loop Recorder Mitral Valve Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death Due to Cardiac Arrhythmia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gottsegen National Cardiovascular Institute

Budapest, 1096, Hungary

Location status: Recruiting

Location contact

Attila Kardos, MD PhD

CONTACT

[email protected]

+36703388864

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

loop recorder implantation

Device

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.

Other names: ILR implantation

Primary outcomes

  1. Ventricular arrhythmia screened with loop recorder

    Time frame: 24 months

    Periprocedurally, at 6-, 12-, 18- and 24-month follow-up, we perform control examinations (e.g. 12-lead ECG, echocardiography, ILR interrogation). Arrhythmias recorded by ILR are documented and analyzed. Our results may contribute to a better understanding of the indications for ILR and ICD implantation in patients with MAD, thereby helping to reduce the risk of sudden cardiac death.

Study contacts

Contact information is provided by the study sponsor or research team.

Attila Kardos, MD PhD

CONTACT

[email protected]

+36703388864

Sara Mladoniczky, MD

CONTACT

[email protected]

+36301550424

Sponsors and collaborators

Lead sponsor

Gottsegen National Cardiovascular Institute

Other

Collaborators

  • Biotronik SE & Co. KG

Registry information

Acronym: ILR MAD IIT

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Feb 27, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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