Electrocardiogram (ECG) Recordings in Paediatric Population

Completed

• Conditions: Arrhythmia

• Registration Number: NCT00399386
• Lead Sponsor: Boston Scientific Corporation

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

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-10
• Study First Submitted QC: 2006-11-10
• Study First Posted: 2006-11-14
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-10
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Bristol Childrens' Hospital; 🇬🇧 Bristol, Avon, United Kingdom