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Clinical Trials/NCT00399386
NCT00399386
Completed
Not Applicable

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

Boston Scientific Corporation1 site in 1 country62 target enrollmentNovember 2006
ConditionsArrhythmia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arrhythmia
Sponsor
Boston Scientific Corporation
Enrollment
62
Locations
1
Status
Completed
Last Updated
9 years ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
November 2006
End Date
October 2008
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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