NCT07436962 Loop Recorder Implantation in Patients With Mitral Annular Disjunction
| NCT ID | NCT07436962 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gottsegen National Cardiovascular Institute |
| Condition | Mitral Annular Disjunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-05 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-12-05 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
Eligibility Criteria
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
Contact & Investigator
Attila Kardos, MD PhD
PRINCIPAL INVESTIGATOR
Gottsegen National Cardiovascular Institute
Frequently Asked Questions
Who can join the NCT07436962 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Mitral Annular Disjunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07436962 currently recruiting?
Yes, NCT07436962 is actively recruiting participants. Contact the research team at attila.kardos@gokvi.hu for enrollment information.
Where is the NCT07436962 trial being conducted?
This trial is being conducted at Budapest, Hungary.
Who is sponsoring the NCT07436962 clinical trial?
NCT07436962 is sponsored by Gottsegen National Cardiovascular Institute. The principal investigator is Attila Kardos, MD PhD at Gottsegen National Cardiovascular Institute. The trial plans to enroll 20 participants.