NCT00399386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

February 16, 2017

Status Verified

October 1, 2009

Enrollment Period

1.9 years

First QC Date

November 10, 2006

Last Update Submit

February 14, 2017

Conditions

Arrhythmia

Keywords

S ICDICDAblationEP studyPaediatricECG

Interventions

EPPROCEDURE
ICDPROCEDURE
AblationPROCEDURE

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients at the Bristol Royal Hospital for Children

You may qualify if:

  • Patients \< 18 years of age
  • Patient scheduled for an EP study, implantation of an ICD or for an ablation procedure

You may not qualify if:

  • Patients whose parents/guardians do not sign an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristol Childrens' Hospital

Bristol, Avon, BS2 8BJ, United Kingdom

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Graham Stuart, MD

    Bristol Childrens' Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2006

First Posted

November 14, 2006

Study Start

November 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 16, 2017

Record last verified: 2009-10

Locations

GB(1)