Long Term Integrity Follow-up Evaluation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00848835

Acronym

LEAD LIFE

Enrollment

372

Registered

2009-02-20

Start date

2002-03-31

Completion date

2010-01-31

Last updated

2010-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden Cardiac Death

Keywords

defibrillator

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.

Interventions

DEVICEdefibrillation lead (ENDOTAK EZ and RELIANCE)

defibrillation lead

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026