ArrhythmiaNCT00399386
Electrocardiogram (ECG) Recordings in Paediatric Population
An observational study of Arrhythmia, run by Boston Scientific Corporation at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Arrhythmia
- What is being tested?
- EP, ICD and Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2006to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients at the Bristol Royal Hospital for Children
Who may be able to join
- Patients < 18 years of age
- Patient scheduled for an EP study, implantation of an ICD or for an ablation procedure
Who cannot join
- Patients whose parents/guardians do not sign an informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bristol Childrens' Hospital
Bristol, Avon, BS2 8BJ
About this study
Official title: ECG Recordings From EP Study, Defibrillator Implantation or Ablation Procedure in Paediatric Population
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.
Read the 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
- Conditions
- Arrhythmia
- Being tested
- EP, ICD, Ablation
- Keywords
- S ICD, ICD, Ablation, EP study, Paediatric, ECG
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPProcedure or surgery
ICDProcedure or surgery
AblationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Graham Stuart, MD, Principal investigator, Bristol Childrens' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399386
- Sponsor's protocol ID
- DN-05039
- Status last verified
- Oct 2009
- First submitted
- 10 Nov 2006
- Last updated
- 16 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECG Recordings From EP Study, Defibrillator Implantation or Ablation Procedure in Paediatric Population
- ClinicalTrials.gov ID
- NCT00399386
- Acronym / sponsor ID
- DN-05039
- Conditions
- Arrhythmia
- Keywords
- S ICD, ICD, Ablation, EP study, Paediatric, ECG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 14 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients at the Bristol Royal Hospital for Children
Key inclusion criteria (2 listed)
- Patients < 18 years of age
- Patient scheduled for an EP study, implantation of an ICD or for an ablation procedure
Key exclusion criteria (1 listed)
- Patients whose parents/guardians do not sign an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EP | Procedure or surgery | – |
| ICD | Procedure or surgery | – |
| Ablation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham Stuart, MD principal investigator
Bristol Childrens' Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia, run by Boston Scientific Corporation at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.