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Canadian Registry of ICD Implant Testing Procedures

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ClinicalTrials.gov Identifier: NCT00848341
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : February 20, 2009
Information provided by:
Guidant Corporation

Brief Summary:
To document practices in Canadian ICD implant centres around defibrillation therapy efficacy testing.

Condition or disease Intervention/treatment Phase
Ventricular Fibrillation Device: GUIDANT ICD SYSTEM Phase 4

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
Actual Enrollment : 261 participants
Time Perspective: Prospective
Official Title: Canadian Registry of ICD Implant Testing Procedures
Study Start Date : January 2006
Primary Completion Date : April 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment

Primary Outcome Measures :
  1. to systematically collect and quanitfy characteristics of ICD implant procedures in Canadian Hospitals [ Time Frame: 3 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who are indicated for a market approved ICD

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848341

Sponsors and Collaborators
Guidant Corporation
Principal Investigator: Stuart Connolly, MD Hamilton Health Sciences Center

Responsible Party: Dr Jeff Healey, hamilton health sciences center
ClinicalTrials.gov Identifier: NCT00848341     History of Changes
Other Study ID Numbers: CREDIT
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes