Electrocardiogram (ECG) Recordings in Paediatric Population

This study is currently recruiting participants.

Verified by Cameron Health, Inc., November 2006

First Received: November 10, 2006 Last Updated: November 27, 2006 History of Changes

Sponsored by:	Cameron Health, Inc.
Information provided by:	Cameron Health, Inc.
ClinicalTrials.gov Identifier:	NCT00399386

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

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title:	ECG Recordings From EP Study, Defibrillator Implantation or Ablation Procedure in Paediatric Population

Further study details as provided by Cameron Health, Inc.:

Estimated Enrollment:	50
Study Start Date:	November 2006

Detailed Description:

The surface ECGs collected from paediatric patients in normal sinus rhythm and a variety of ventricular and atrial arrhythmias will be used as test sginals 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 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts

Contact: Graham Stuart, MD

+44 117 923 0000

graham.stuart@ubht.swest.nhs.uk

Locations

United Kingdom, Avon
Bristol Childrens' Hospital	Recruiting
Bristol, Avon, United Kingdom, BS2 8BJ
Principal Investigator: Graham Stuart, MD

Sponsors and Collaborators

Cameron Health, Inc.

Investigators

Principal Investigator:

Graham Stuart, MD

Bristol Childrens' Hospital

More Information

No publications provided

Study ID Numbers:	DN-05039
Study First Received:	November 10, 2006
Last Updated:	November 27, 2006
ClinicalTrials.gov Identifier:	NCT00399386 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Cameron Health, Inc.:

S ICD
ICD
Ablation

EP study
Paediatric
ECG

Study placed in the following topic categories:

Heart Diseases
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009