Canadian Registry of ICD Implant Testing Procedures

February 19, 2009 updated by: Guidant Corporation
To document practices in Canadian ICD implant centres around defibrillation therapy efficacy testing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

261

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who are indicated for a market approved ICD

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Device: GUIDANT ICD SYSTEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to systematically collect and quanitfy characteristics of ICD implant procedures in Canadian Hospitals
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guidant Corporation

Investigators

  • Principal Investigator: Stuart Connolly, MD, Hamilton Health Sciences Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

February 19, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (Estimate)

February 20, 2009

Study Record Updates

Last Update Posted (Estimate)

February 20, 2009

Last Update Submitted That Met QC Criteria

February 19, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREDIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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