Canadian Registry of ICD Implant Testing Procedures - Full Text View

Sponsored by:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00848341

Purpose

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

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Study placed in the following topic categories:

Paroxysmal Ventricular Fibrillation
Heart Diseases
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Ventricular Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on August 30, 2009