Loop Recorder Implantation in Patients With Mitral Annular Disjunction (ILR MAD IIT)

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.

Study Overview

• Status: Recruiting
• Conditions: Sudden Cardiac Death Due to Cardiac Arrhythmia; Mitral Valve; Loop Recorder; Arrhythmia Ventricular; Mitral Annular Disjunction
• Intervention / Treatment: Device: loop recorder implantation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Attila Kardos, MD PhD; Phone Number: +36703388864; Email: attila.kardos@gokvi.hu
• Study Contact Backup: Name: Sara Mladoniczky, MD; Phone Number: +36301550424; Email: sara.mladoniczky@gokvi.hu

Study Locations

• Hungary
  • Budapest, Hungary, 1096
    • Recruiting
    • Gottsegen National Cardiovascular Institute
    • Contact: Attila Kardos, MD PhD; Phone Number: +36703388864; Email: attila.kardos@gokvi.hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MAD-ILR; Patients with mitral annular disjunction, confirmed by echocardiography and MR scan confirmed late-type gadolinium enhancement in the myocardium, undergoing loop recorder implantation.

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.; Other Names: ILR implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventricular arrhythmia screened with loop recorder	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.	24 months

Collaborators and Investigators

• Sponsor: Gottsegen National Cardiovascular Institute
• Collaborators: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Attila Kardos, MD PhD, Gottsegen National Cardiovascular Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: mitral annular disjunction; ventricular arrhythmia; MAD; sudden cardiac death; mitral valve; loop recorder
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Death; Heart Arrest; Death, Sudden; Pathological Conditions, Signs and Symptoms; Death, Sudden, Cardiac
• Other Study ID Numbers: 1034; FF110 (Other Grant/Funding Number: BIOTRONIK SE & Co. KG)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No