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Canadian Registry of ICD Implant Testing Procedures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00848341
First Posted: February 20, 2009
Last Update Posted: February 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Guidant Corporation
  Purpose
To document practices in Canadian ICD implant centres around defibrillation therapy efficacy testing.

Condition Intervention Phase
Ventricular Fibrillation Device: GUIDANT ICD SYSTEM Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Canadian Registry of ICD Implant Testing Procedures

Resource links provided by NLM:


Further study details as provided by Guidant Corporation:

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

Enrollment: 261
Study Start Date: January 2006
Study Completion Date: November 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Control Device: GUIDANT ICD SYSTEM

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.
  Eligibility

Information from the National Library of Medicine

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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
Criteria

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)
  Contacts and Locations
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
Investigators
Principal Investigator: Stuart Connolly, MD Hamilton Health Sciences Center
  More Information

Responsible Party: Dr Jeff Healey, hamilton health sciences center
ClinicalTrials.gov Identifier: NCT00848341     History of Changes
Other Study ID Numbers: CREDIT
First Submitted: February 19, 2009
First Posted: February 20, 2009
Last Update Posted: February 20, 2009
Last Verified: February 2009

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