Arrhythmia Ventricular, Loop Recorder, Mitral Annular Disjunction, Mitral Valve, Sudden Cardiac Death Due to Cardiac Arrhythmia
Conditions
Keywords
mitral annular disjunction, MAD, sudden cardiac death, loop recorder, ventricular arrhythmia, mitral valve
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.
Interventions
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.
Sponsors
Gottsegen National Cardiovascular Institute
Biotronik SE & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventricular arrhythmia screened with loop recorder | 24 months | 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. |
Countries
Hungary
Contacts
CONTACTAttila Kardos, MD PhD
CONTACTSara Mladoniczky, MD
PRINCIPAL_INVESTIGATORAttila Kardos, MD PhD
Gottsegen National Cardiovascular Institute
Outcome results
None listed