Electrocardiogram (ECG) Recordings in Paediatric Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00399386
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : February 16, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Arrhythmia Procedure: EP Procedure: ICD Procedure: Ablation

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 Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ECG Recordings From EP Study, Defibrillator Implantation or Ablation Procedure in Paediatric Population
Study Start Date : November 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

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U.S. FDA Resources

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Boston Scientific Corporation Identifier: NCT00399386     History of Changes
Other Study ID Numbers: DN-05039
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: October 2009

Keywords provided by Boston Scientific Corporation:
EP study