Long Term Integrity Follow-up Evaluation | NCT00848835

Studies
Long Term Integrity Follow-up Evaluation

NCT00848835

Sponsor

Guidant Corporation

Status

Completed

Last Update Posted

Aug 31, 2010Estimated

Enrollment

372Actual

Phase

Not provided

Conditions

Sudden Cardiac Death

Interventions

defibrillation lead (ENDOTAK EZ and RELIANCE)

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

Aug 2010

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

Mar 2002

Primary Completion Date

Oct 2009Actual

Completion Date

Jan 2010Actual

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

Aug 30, 2010

Last Update Posted Date

Aug 31, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 the performance of the Guidant ENDOTAK EZ and the RELIANCE defibrillation leads over 5 years.

Detailed Description

There are few prospective long term follow-up studies on implanted cardiac device (pacemaker/implantable cardioverter defibrillator (ICD)) survivability. This study will evaluate the long term performance (5 years) of the transvenous defibrillation leads (ENDOTAK ENDURANCE EZ and teh ENDOTAK RELIANCE. Data will be collected at implant, 1 and 6 months, 1,3 and 5 years.

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

372Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control		all patients in the control group	Device: defibrillation lead (ENDOTAK EZ and RELIANCE)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
defibrillation lead (ENDOTAK EZ and RELIANCE)	Device	defibrillation lead	control

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients selected for Guidant ICD system implant, available for follow-up at the defined intervals

Exclusion Criteria:

Patients enrolled in other studies, not available for follow-up, < 18 yrs, unable to sign consent, life expectancy < 1 year due to a medical condition

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

all patients who are indicated for a market released ICD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lawrence Sterns, MD	Victoria Cardiac Arrythmia trials	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016757	Death, Sudden, Cardiac

Ancestor Terms

ID	Term
D006323	Heart Arrest
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D003645	Death, Sudden

Browse Leaves

Not provided

Browse Branches

Not provided