Loop Recorder Implantation in Patients With Mitral Annular Disjunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: loop recorder implantation.
- Who it may be relevant to
- Registry conditions: Mitral Annular Disjunction, Mitral Valve, Arrhythmia Ventricular, Sudden Cardiac Death Due to Cardiac Arrhythmia. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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,
Primary outcome measures
- Ventricular arrhythmia screened with loop recorder [Time frame: 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Hungary · 1 center
- Gottsegen National Cardiovascular Institute — Budapest
Identifiers
NCT: NCT07436962 · 1034 · FF110