Long Term Integrity Follow-up Evaluation (LEAD LIFE)

This study has been completed.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00848835
First received: February 19, 2009
Last updated: August 30, 2010
Last verified: August 2010
  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 4

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

Further study details as provided by Guidant Corporation:

Enrollment: 372
Study Start Date: March 2002
Study Completion Date: January 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Anne Swearingen, Boston Scientific
ClinicalTrials.gov Identifier: NCT00848835     History of Changes
Other Study ID Numbers: LEAD LIFE
Study First Received: February 19, 2009
Last Updated: August 30, 2010
Health Authority: Canada: Health Canada

Keywords provided by Guidant Corporation:
defibrillator

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Death
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014