Loop Recorder Implantation in Patients With Mitral Annular Disjunction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Ventricular arrhythmia screened with loop recorder
Study Overview
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:
- Screening of asymptomatic patients with MAD for arrhythmia.
- In case of symptoms, to prove or exclude the underlying arrhythmia.
BioMonitor IIIm ILR implantation is planned in the following patient population:
- Inclusion of 20 patients with mitral annular disjunction confirmed by echocardiography and late gadolinium enhancement in the myocardium by MRI.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
- •previous ICD implantation
- •indication for ICD or ILR implantation based on current recommendation
Arms & Interventions
MAD-ILR
Patients with mitral annular disjunction, confirmed by echocardiography and MR scan confirmed late-type gadolinium enhancement in the myocardium, undergoing loop recorder implantation.
Intervention: loop recorder implantation (Device)
Outcomes
Primary Outcomes
Ventricular arrhythmia screened with loop recorder
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported