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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023529

Enrollment

Registered

2020-11-06

Start date

2021-01-01

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis or exclusion of atrial and ventriculararrhythmias in children with and without congenitalheart defects I49

Interventions

Group 1: In P1, all patients who meet the inclusion criteria and who have agreed to participate in the study are placed in several positions of the Holter ECG system and short ECG recordings are taken

Eligibility

Sex/Gender

All

Age

No minimum to 18 Years

Inclusion 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 surgery - Phase 2: Indication for a 24h (72h) Holter ECG according to recognised national and international guidelines

Exclusion criteria

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Germany

Contacts

Public ContactPeter Kramer

Deutsches Herzzentrum der Charité, Klinik für Angeborene Herzfehler - Kinderkardiologie

peter.kramer@dhzc-charite.de+493045932800

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026