Canadian Registry of ICD Implant Testing Procedures | NCT00848341

Studies
Canadian Registry of ICD Implant Testing Procedures

NCT00848341

Sponsor

Guidant Corporation

Status

Completed

Last Update Posted

Feb 20, 2009Estimated

Enrollment

261Actual

Phase

Not provided

Conditions

Ventricular Fibrillation

Interventions

GUIDANT ICD SYSTEM

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Apr 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Feb 19, 2009

First Submission Date that Met QC Criteria

Feb 19, 2009

First Posted Date

Feb 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2009

Last Update Posted Date

Feb 20, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

261Actual

Label	Type	Description	Intervention Names
Control			Device: GUIDANT ICD SYSTEM

Name	Type	Description	Arm Group Labels	Other Names
GUIDANT ICD SYSTEM	Device		Control

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients who are indicated for a market approved ICD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stuart Connolly, MD	Hamilton Health Sciences Center	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014693	Ventricular Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided