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

Recruiting

• Conditions: Diagnosis or exclusion of atrial and ventriculararrhythmias in children with and without congenitalheart defects; I49; Other cardiac arrhythmias

• Registration Number: DRKS00023529
• Lead Sponsor: Deutsches Herzzentrum der Charité, Klinik für Angeborene Herzfehler - Kinderkardiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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
surgery
- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Determination of the optimal weight-adapted<br>positioning of the mini-long-term ECG in<br>children and adolescents.<br>2. Comparison of the standard 24h ECG and the<br>mini-long-term ECG in children and<br>adolescents.<br>a. Is the signal quality of the mini-longterm ECG better?<br>b. Does the mini long-term ECG record<br>more arrhythmias in the observation<br>period of seven days than the standard<br>24h long-term ECG?<br>c. Are there differences in the application<br>in childhood and adolescence?<br>d. How is the (significantly smaller) mini<br>long-term ECG tolerated by patients in<br>everyday life (compared to the<br>standard 24-hour long-term ECG)?<br>Does a (facultative) better tolerance<br>lead to a better evaluation (e.g.<br>through longer derivation time or lower<br>artefact rate)?<br>

Secondary Outcome Measures

Name	Time	Method
How were the recording methods assessed in terms of their handling<br>1. by the study participants regarding<br>a. Skin irritations<br>b. Durability of the electrodes without re-fixing<br>i. Restriction in movement,<br>ii. Restriction of personal hygiene,<br>iii. other restrictions?<br>2. by the users regarding<br>a. Attaching and removing the devices<br>b. Compliance of patients and relatives<br>