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Electrocardiogram (ECG) Recordings in Paediatric Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00399386
First received: November 10, 2006
Last updated: February 14, 2017
Last verified: October 2009
  Purpose
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
  Eligibility

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399386

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

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov 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:
S ICD
ICD
Ablation
EP study
Paediatric
ECG

ClinicalTrials.gov processed this record on April 24, 2017