Electrocardiogram (ECG) Recordings in Paediatric Population

NCT ID: NCT00399386

Last Updated: 2017-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-10-31

Brief Summary

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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

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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

Conditions

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Arrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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EP

Intervention Type PROCEDURE

ICD

Intervention Type PROCEDURE

Ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Graham Stuart, MD

Role: PRINCIPAL_INVESTIGATOR

Bristol Childrens' Hospital

Locations

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Bristol Childrens' Hospital

Bristol, Avon, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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DN-05039

Identifier Type: -

Identifier Source: org_study_id

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