Electrocardiogram (ECG) Recordings in Paediatric Population

This study has been completed.
Sponsor:
Information provided by:
Cameron Health, Inc.
ClinicalTrials.gov Identifier:
NCT00399386
First received: November 10, 2006
Last updated: October 8, 2009
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 Cameron Health, Inc.:

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
Genders Eligible for Study:   Both
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
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
Cameron Health, Inc.
Investigators
Principal Investigator: Graham Stuart, MD Bristol Childrens' Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00399386     History of Changes
Other Study ID Numbers: DN-05039
Study First Received: November 10, 2006
Last Updated: October 8, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Cameron Health, Inc.:
S ICD
ICD
Ablation
EP study
Paediatric
ECG

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014