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Electrocardiogram (ECG) Recordings in Paediatric Population

ECG Recordings From EP Study, Defibrillator Implantation or Ablation Procedure in Paediatric Population

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00399386
Enrollment
62
Registered
2006-11-14
Start date
2006-11-30
Completion date
2008-10-31
Last updated
2017-02-16

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

Conditions

Arrhythmia

Keywords

S ICD, ICD, Ablation, EP study, Paediatric, ECG

Brief summary

The primary goal of this protocol is to collect ECG signals from paediatric patients using 4 surface electrodes placed in the configurations proposed for the Cameron Health, Inc. subcutaneous implantable defibrillator (S-ICD) system. These signals will then be used to test the S-ICD system for future use in paediatric patients.

Detailed description

The surface ECGs collected from pediatric patients in normal sinus rhythm and a variety of ventricular and atrial arrhythmias will be used as test signals for the development of the S-ICD system. These signals will be collected from patients undergoing electrophysiology (EP) study, transvenous defibrillator implantation or ablation procedures

Interventions

PROCEDUREEP
PROCEDUREICD
PROCEDUREAblation

Sponsors

Boston Scientific Corporation
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* Patients \< 18 years of age * Patient scheduled for an EP study, implantation of an ICD or for an ablation procedure

Exclusion criteria

* Patients whose parents/guardians do not sign an informed consent

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026