Actively Recruiting
Loop Recorder Implantation in Patients With Mitral Annular Disjunction
Led by Gottsegen National Cardiovascular Institute · Updated on 2026-03-02
20
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
G
Gottsegen National Cardiovascular Institute
Lead Sponsor
B
Biotronik SE & Co. KG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Loop Recorder Implantation in Patients With Mitral Annular Disjunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years
- Patient is not incapacitated
- Mitral annular disjunction confirmed by echocardiography
- Late-type gadolinium enhancement in the myocardium confirmed by MRI scan
You will not qualify if you...
- Lack of informed consent
- Age under 18 years
- Limited capability
- Under guardianship
- Active infection
- Cancer
- Previous ICD implantation
- Indication for ICD or ILR implantation based on current guidelines
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gottsegen National Cardiovascular Institute
Budapest, Hungary, 1096
Actively Recruiting
Research Team
A
Attila Kardos, MD PhD
CONTACT
S
Sara Mladoniczky, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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