Canadian Registry of ICD Implant Testing Procedures

This study has been completed.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00848341
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848341

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

No publications provided

Responsible Party: Dr Jeff Healey, hamilton health sciences center
ClinicalTrials.gov Identifier: NCT00848341     History of Changes
Other Study ID Numbers: CREDIT
Study First Received: February 19, 2009
Last Updated: February 19, 2009
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 30, 2014