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
104 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
Researchers are investigating the occurrence of arrhythmia in young adults aged 18 to 60 who have mitral annular disjunction confirmed by echocardiography and late-type gadolinium enhancement in the myocardium detected by MRI. This group has an increased risk of dangerous ventricular arrhythmias and sudden cardiac death but currently does not meet guidelines for implantable cardioverter defibrillator (ICD) or implantable loop recorder (ILR) use. The study aims to screen asymptomatic patients and clarify arrhythmia presence in those with mild or uncertain symptoms such as dizziness or palpitations. The study involves implanting the BioMonitor IIIm implantable loop recorder in 20 patients over one year. This device is placed during a minor outpatient surgery under local anesthesia through a small chest incision, with absorbable sutures used to close the wound. After implantation, patients are discharged the same day and can maintain their normal lifestyle, although they should avoid strong magnetic fields to prevent signal interference. Participants will be monitored for ventricular arrhythmias using the loop recorder for up to 24 months. Researchers will collect data on arrhythmia prevalence and correlate symptoms with recorded heart activity. The study includes regular follow-ups and safety assessments, focusing on arrhythmia detection and device performance. The total participation time can extend over two years, allowing for long-term observation of heart rhythm abnormalities in this specific patient population.
CONDITIONS
Brief 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 myocardium confirmed by MRI
You will not qualify if you...
- Lack of informed consent
- Under 18 years of age
- Limited capability
- Under guardianship
- Active infection
- Cancer
- Previous ICD implantation
- Indication for ICD or ILR implantation based on current recommendations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day for procedure plus about 10 days for wound healing
Participants undergo outpatient loop recorder implantation involving a small chest incision under local anesthesia. The wound is closed with absorbable sutures, and healing takes about 10 days with a covering bandage. Participants are discharged on the day of the procedure with lifestyle allowed except for avoiding strong magnetic fields.
1 outpatient surgery visit
Duration - 24 months
Participants are monitored for ventricular arrhythmia using the implanted loop recorder over an extended period.
Regular monitoring visits as scheduled by study
Trial Site Locations
Total: 1 location
1
Gottsegen National Cardiovascular Institute
Budapest, Hungary, 1096
Actively Recruiting
Research Team
A
Attila Kardos, MD PhD
S
Sara Mladoniczky, MD
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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