Canadian Registry of ICD Implant Testing Procedures
This study has been completed.
Sponsor:
Guidant Corporation
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 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 May 23, 2013