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Long Term Integrity Follow-up Evaluation

NCT ID: NCT00848835

Last Updated: 2010-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-03-31

Study Completion Date

2010-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Sudden Cardiac Death

Keywords

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defibrillator

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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control

all patients in the control group

defibrillation lead (ENDOTAK EZ and RELIANCE)

Intervention Type DEVICE

defibrillation lead

Interventions

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defibrillation lead (ENDOTAK EZ and RELIANCE)

defibrillation lead

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guidant Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Boston Scientific

Principal Investigators

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Lawrence Sterns, MD

Role: PRINCIPAL_INVESTIGATOR

Victoria Cardiac Arrythmia trials

Other Identifiers

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LEAD LIFE

Identifier Type: -

Identifier Source: org_study_id