- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00848341
Canadian Registry of ICD Implant Testing Procedures
February 19, 2009 updated by: Guidant Corporation
To document practices in Canadian ICD implant centres around defibrillation therapy efficacy testing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
261
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients who are indicated for a market approved ICD
Description
Inclusion Criteria:
- Receiving a Guidant ICD system, including replacements
Exclusion Criteria:
- New epicardial lead(s) implanted, included in another cardiovascular trial (may be in the ELECTION Study)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
to systematically collect and quanitfy characteristics of ICD implant procedures in Canadian Hospitals
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stuart Connolly, MD, Hamilton Health Sciences Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
February 19, 2009
First Submitted That Met QC Criteria
February 19, 2009
First Posted (Estimate)
February 20, 2009
Study Record Updates
Last Update Posted (Estimate)
February 20, 2009
Last Update Submitted That Met QC Criteria
February 19, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CREDIT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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