Electrocardiogram (ECG) Recordings in Paediatric Population

Boston Scientific

Status: Completed

Conditions: Arrhythmia

Treatments: Procedure: EP; Procedure: ICD; Procedure: Ablation

Study type: Observational

Funder types: Industry

Identifiers

NCT00399386

DN-05039

Details and patient eligibility

About

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.

Full 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

Enrollment: 62 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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