GALAXY

GALAXY Registry

Long-Term Evaluation of the Linox Family ICD Leads Registry

NCT00836589

Study Design

Multi-center, prospective, non-randomized, 5-year data collection registry
Designed to confirm long-term safety and reliability of BIOTRONIK’s Linox ICD leads
1,997 subjects at 98 US sites

Reference No.	NCT00836589
Study Objective	To confirm long-term safety and reliability of BIOTRONIK’s family of ICD leads, as used in conjunction with BIOTRONIK ICD pulse generators.
1° Endpoints	To evaluate the overall incidence of serious adverse events related to the Linox family of ICD leads. To evaluate the incidence of each type of serious adverse event that contributes to Primary Endpoint 1.
2° Endpoints	Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-enrollment Electrical characteristics of each individual Linox lead system, measured at scheduled GALAXY registry follow ups through 5 years post-enrollment
Clinical Sites	98 US sites
Sample Size	1,997 subjects
Inclusion Criteria	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
Main Exclusion Criteria	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
Devices	Linox and Linox^smart ICD lead systems Leads must be used in conjunction with a BIOTRONIK ICD
Follow-Up	At least once every 6 months per site's institutional standard of care.
Study Duration	Study start date January 2009. Estimated study completion November 2016.