Ventricular FibrillationNCT00848341
Canadian Registry of ICD Implant Testing Procedures
An observational study of Ventricular Fibrillation, run by Guidant Corporation.
Trial summary
To document practices in Canadian ICD implant centres around defibrillation therapy efficacy testing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Fibrillation
- What is being tested?
- GUIDANT ICD SYSTEM
- Type of treatment
- Medical device
- How many people
- 261 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who are indicated for a market approved ICD
Who may be able to join
- Receiving a Guidant ICD system, including replacements
Who cannot join
- New epicardial lead(s) implanted, included in another cardiovascular trial (may be in the ELECTION Study)
About this study
To document practices in Canadian ICD implant centres around defibrillation therapy efficacy testing.
Read the detailed description
To document types of defibrillation testing (DFT) procedures are in current use in Canada, rates of use an dno use of DFT testing, medical indications for non use of DFT testing, rate of successful testing of first lead configuration, rates and types of complications from DFT testing, costs of implant procedures and the costs associated with DFT testing, short term outcomes of patients with different types of implant procedures.
- Conditions
- Ventricular Fibrillation
- Being tested
- GUIDANT ICD SYSTEM
- Medical subject headings
- Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUIDANT ICD SYSTEMDevice
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described Receives: Device: GUIDANT ICD SYSTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
to systematically collect and quanitfy characteristics of ICD implant procedures in Canadian Hospitals
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startJan 2006
- Primary completionApr 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular FibrillationStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guidant Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stuart Connolly, MD, Principal investigator, Hamilton Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848341
- Sponsor's protocol ID
- CREDIT
- Status last verified
- Feb 2009
- First submitted
- 19 Feb 2009
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Registry of ICD Implant Testing Procedures
- ClinicalTrials.gov ID
- NCT00848341
- Acronym / sponsor ID
- CREDIT
- Conditions
- Ventricular Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Guidant CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 20 Feb 2009 (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.
To document practices in Canadian ICD implant centres around defibrillation therapy efficacy testing.
Detailed description
To document types of defibrillation testing (DFT) procedures are in current use in Canada, rates of use an dno use of DFT testing, medical indications for non use of DFT testing, rate of successful testing of first lead configuration, rates and types of complications from DFT testing, costs of implant procedures and the costs associated with DFT testing, short term outcomes of patients with different types of implant procedures.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | – | Device: GUIDANT ICD SYSTEM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who are indicated for a market approved ICD
Key inclusion criteria (1 listed)
- Receiving a Guidant ICD system, including replacements
Key exclusion criteria (1 listed)
- New epicardial lead(s) implanted, included in another cardiovascular trial (may be in the ELECTION Study)
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 |
|---|---|---|
| GUIDANT ICD SYSTEM | Device | Control |
Primary outcome
to systematically collect and quanitfy characteristics of ICD implant procedures in Canadian Hospitals
Time frame: 3 years
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 20 Feb 2009.
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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.
Stuart Connolly, MD principal investigator
Hamilton Health Sciences Center
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Fibrillation, run by Guidant Corporation.
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 1 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 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
to systematically collect and quanitfy characteristics of ICD implant procedures in Canadian Hospitals (time frame: 3 years). It is what the study was designed to measure, not a finding.
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 20 Feb 2009.