Long Term Integrity Follow-up Evaluation

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

Completed

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Key information

Conditions

Sudden Cardiac Death Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

defibrillation lead (ENDOTAK EZ and RELIANCE)

Device

defibrillation lead

Sponsors and collaborators

Lead sponsor

Guidant Corporation

Industry

Registry information

Acronym: LEAD LIFE

Important dates

Study start: 2002
Primary completion: 2009
Study completion: 2010
First posted: Feb 20, 2009
Registry last updated: Aug 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed