NCT00848341

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
Last Updated

February 20, 2009

Status Verified

February 1, 2009

Enrollment Period

2.2 years

First QC Date

February 19, 2009

Last Update Submit

February 19, 2009

Conditions

Ventricular Fibrillation

Outcome Measures

Primary Outcomes (1)

  • to systematically collect and quanitfy characteristics of ICD implant procedures in Canadian Hospitals

    3 years

Study Arms (1)

Control

Device: GUIDANT ICD SYSTEM

Interventions

GUIDANT ICD SYSTEMDEVICE
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who are indicated for a market approved ICD

You may qualify if:

  • Receiving a Guidant ICD system, including replacements

You may not qualify if:

  • New epicardial lead(s) implanted, included in another cardiovascular trial (may be in the ELECTION Study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stuart Connolly, MD

    Hamilton Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

January 1, 2006

Primary Completion

April 1, 2008

Study Completion

November 1, 2008

Last Updated

February 20, 2009

Record last verified: 2009-02