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Clinical Trials/DRKS00023529
DRKS00023529
Recruiting
Not Applicable

Clinical study on the use of a mini long-term ECG in children with congenital heart defectsand primary cardiac arrhythmia

Deutsches Herzzentrum der Charité, Klinik für Angeborene Herzfehler - Kinderkardiologie0 sites50 target enrollmentNovember 6, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diagnosis or exclusion of atrial and ventriculararrhythmias in children with and without congenitalheart defects
Sponsor
Deutsches Herzzentrum der Charité, Klinik für Angeborene Herzfehler - Kinderkardiologie
Enrollment
50
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 6, 2020
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Deutsches Herzzentrum der Charité, Klinik für Angeborene Herzfehler - Kinderkardiologie

Eligibility Criteria

Inclusion Criteria

  • Belonging to weight classes G1 (5\-15kg) or
  • G2 (15\-40kg)
  • \- Consent of the parents as well as the study
  • participant (from the age of 6 years)
  • \- Phase 1: independently planned sedation
  • during a cardiac catheter examination or
  • \- Phase 2: Indication for a 24h (72h) Holter
  • ECG according to recognised national and
  • international guidelines

Exclusion Criteria

  • \- Atypical situs or atypical axis of the heart (e.g. dextrocardia, mesocardia)
  • \- Severe thoracic deformity (e.g. severe scoliosis)
  • \- known AV replacement rhythm
  • \- fresh thoracotomy (the wound healing must be completed)
  • \- open wounds on the thorax, skin infections or inflammations on the thorax or in the area of the planned fixation of the mini long\-term ECG
  • \- Implanted pacemaker/cardioverter defibrillators (ICD), CRTs (cardiac resynchronisation)
  • \- Planned MRT examination during the study period

Outcomes

Primary Outcomes

Not specified

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