Status:
COMPLETED
Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)
Lead Sponsor:
Biotronik, Inc.
Conditions:
Patients Indicated for an ICD
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to confirm the long-term safety and reliability of the Linox Lead System as used with BIOTRONIK ICDs. The GALAXY registry will provide data to fully characterize ICD lea...
Detailed Description
This study is a multi-center, prospective, non-randomized, 5-year data collection registry. Eligible patients must have been successfully implanted with a Linox Lead System connected to a BIOTRONIK IC...
Eligibility Criteria
Inclusion
- Successfully implanted Linox Lead System connected to a BIOTRONIK ICD, from 1-45 days prior to enrollment
- Able to understand the nature of the registry and provide informed consent
- Available for follow-up visits on a regular basis at the investigational site
- Age greater than or equal to 18 years
Exclusion
- Enrolled in any IDE clinical study
- Planned cardiac surgical procedures or investigational measures within the next 6 months
- Expected to receive a heart transplant within 1 year
- Life expectancy less than 1 year
- Presence of another life-threatening, underlying illness separate from their cardiac disorder
- Pregnancy
- Inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
1997 Patients enrolled
Trial Details
Trial ID
NCT00836589
Start Date
December 1 2008
End Date
December 1 2016
Last Update
February 15 2019
Active Locations (85)
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1
Albertville, Alabama, United States
2
Birmingham, Alabama, United States
3
Gadsden, Alabama, United States
4
Jasper, Alabama, United States