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Long Term Integrity Follow-up Evaluation (LEAD LIFE)

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ClinicalTrials.gov Identifier: NCT00848835
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : August 31, 2010
Sponsor:
Information provided by:
Guidant Corporation

Study Description
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Brief Summary:
To document the performance of the Guidant ENDOTAK EZ and the RELIANCE defibrillation leads over 5 years.

Condition or disease Intervention/treatment
Sudden Cardiac Death Device: defibrillation lead (ENDOTAK EZ and RELIANCE)

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.
Study Design
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Study Type : Observational
Actual Enrollment : 372 participants
Time Perspective: Prospective
Official Title: Long Term Integrity Follow-up Evaluation
Study Start Date : March 2002
Actual Primary Completion Date : October 2009
Actual Study Completion Date : January 2010
Groups and Cohorts
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Group/Cohort Intervention/treatment
control
all patients in the control group
 Device: defibrillation lead (ENDOTAK EZ and RELIANCE)
defibrillation lead


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients who are indicated for a market released ICD
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848835


Sponsors and Collaborators
Guidant Corporation
Investigators
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Principal Investigator: Lawrence Sterns, MD Victoria Cardiac Arrythmia trials
More Information
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Responsible Party: Anne Swearingen, Boston Scientific
ClinicalTrials.gov Identifier: NCT00848835    
Other Study ID Numbers: LEAD LIFE
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: August 31, 2010
Last Verified: August 2010
Keywords provided by Guidant Corporation:
defibrillator
Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Death
Pathologic Processes
Heart Arrest
 Heart Diseases
Cardiovascular Diseases
Death, Sudden