Long Term Integrity Follow-up Evaluation - Full Text View

Long Term Integrity Follow-up Evaluation (LEAD LIFE)

This study is ongoing, but not recruiting participants.

First Received: February 19, 2009 No Changes Posted

Sponsored by:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00848835

Purpose

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

Condition	Intervention	Phase
Sudden Cardiac Death	Device: defibrillation lead (ENDOTAK EZ and RELIANCE)	Phase IV

Study Type:	Observational
Study Design:	Prospective
Official Title:	Long Term Integrity Follow-up Evaluation

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest

U.S. FDA Resources

Further study details as provided by Guidant Corporation:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	372
Study Start Date:	March 2002
Estimated Study Completion Date:	December 2010

Groups/Cohorts	Assigned Interventions
control all patients in the control group	Device: defibrillation lead (ENDOTAK EZ and RELIANCE) defibrillation lead

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848835

Sponsors and Collaborators

Guidant Corporation

Investigators

Principal Investigator:

Lawrence Sterns, MD

Victoria Cardiac Arrythmia trials

More Information

No publications provided

Responsible Party:	Boston Scientific ( Anne Swearingen )
Study ID Numbers:	LEAD LIFE
Study First Received:	February 19, 2009
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00848835 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Guidant Corporation:

defibrillator

Study placed in the following topic categories:

Death
Heart Diseases
Death, Sudden
Heart Arrest
Death, Sudden, Cardiac

Additional relevant MeSH terms:

Death
Pathologic Processes
Heart Diseases
Death, Sudden

Cardiovascular Diseases
Heart Arrest
Death, Sudden, Cardiac

ClinicalTrials.gov processed this record on August 30, 2009