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Electrocardiogram (ECG) Recordings in Paediatric Population

This study has been completed.
Information provided by (Responsible Party):
Boston Scientific Corporation Identifier:
First received: November 10, 2006
Last updated: February 14, 2017
Last verified: October 2009
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.

Condition Intervention
Arrhythmia Procedure: EP Procedure: ICD Procedure: Ablation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ECG Recordings From EP Study, Defibrillator Implantation or Ablation Procedure in Paediatric Population

Resource links provided by NLM:

Further study details as provided by Boston Scientific Corporation:

Enrollment: 62
Study Start Date: November 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients at the Bristol Royal Hospital for Children

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00399386

United Kingdom
Bristol Childrens' Hospital
Bristol, Avon, United Kingdom, BS2 8BJ
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: Graham Stuart, MD Bristol Childrens' Hospital
  More Information

Responsible Party: Boston Scientific Corporation Identifier: NCT00399386     History of Changes
Other Study ID Numbers: DN-05039
Study First Received: November 10, 2006
Last Updated: February 14, 2017

Keywords provided by Boston Scientific Corporation:
EP study
ECG processed this record on September 25, 2017