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Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID07436962

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

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Research Team

A

Attila Kardos, MD PhD

S

Sara Mladoniczky, MD

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