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NCT00399386 Clinical Trial

Electrocardiogram (ECG) Recordings in Paediatric Population

Arrhythmia Clinical Trial

Official title:
ECG Recordings From EP Study, Defibrillator Implantation or Ablation Procedure in Paediatric Population

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00399386
Other study ID # DN-05039
Secondary ID
Status Completed
Phase N/A
First received November 10, 2006
Last updated February 14, 2017
Start date November 2006
Est. completion date October 2008

Study information
Verified date October 2009
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• EP

• ICD

• Ablation

Locations
Country Name City State
United Kingdom Bristol Childrens' Hospital Bristol Avon

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United Kingdom, 

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