Canadian Registry of ICD Implant Testing Procedures

Ventricular Fibrillation Clinical Trial

Official title:

Canadian Registry of ICD Implant Testing Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848341
• Other study ID #: CREDIT
• Status: Completed
• Phase: Phase 4
• First received: February 19, 2009
• Last updated: February 19, 2009
• Start date: January 2006
• Est. completion date: November 2008

Study information

• Verified date: February 2009
• Source: Guidant Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: November 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Ventricular Fibrillation

Intervention

Device:
• GUIDANT ICD SYSTEM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guidant Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to systematically collect and quanitfy characteristics of ICD implant procedures in Canadian Hospitals		3 years	No