NCT07436962

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. 1.Screening of asymptomatic patients with MAD for arrhythmia.
  2. 2.In case of symptoms, to prove or exclude the underlying arrhythmia.
  3. 3.Inclusion of 20 patients with mitral annular disjunction confirmed by echocardiography and late gadolinium enhancement in the myocardium by MRI.
  4. 4.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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
46mo left

Started Dec 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Dec 2025Feb 2030

Study Start

First participant enrolled

December 5, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

February 20, 2026

Last Update Submit

February 27, 2026

Conditions

Mitral Annular DisjunctionMitral ValveArrhythmia VentricularSudden Cardiac Death Due to Cardiac ArrhythmiaLoop Recorder

Keywords

mitral annular disjunctionMADsudden cardiac deathloop recorderventricular arrhythmiamitral valve

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

MAD-ILR

EXPERIMENTAL

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

Interventions

loop recorder implantationDEVICE

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.

Also known as: ILR implantation
MAD-ILR

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gottsegen National Cardiovascular Institute

Budapest, 1096, Hungary

RECRUITING

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Attila Kardos, MD PhD

    Gottsegen National Cardiovascular Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Attila Kardos, MD PhD

CONTACT

+36703388864attila.kardos@gokvi.hu

Sara Mladoniczky, MD

CONTACT

+36301550424sara.mladoniczky@gokvi.hu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 27, 2026

Study Start

December 5, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2030

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)