GALAXY

GALAXY Registry

Long-term Evaluation of the Linox Family ICD Leads Registry

Study Design

  • Multi-center , prospective, non-randomized, FDA reviewed, observational study
  • Designed to confirm long-term safety and reliability of BIOTRONIK’s Linox ICD leads
  • 1,997 patients at 98 USA centers - This study is ongoing

Recent publication1 with results from the ongoing GALAXY and CELESTIAL studies demonstrate favorable lead survival probabilities

Clinical Relevance

  • Linox and Linoxsmart ICD leads are safe, reliable and infrequently associated with lead-related adverse events (AEs)
  • Estimated cumulative survival probability is favourable and well within industry standards
  • Scientifically sound analysis due to multi-center, high enrollment, prospective study design as well as adjudication of AEs by an independent panel of five EPs
  • Most extensive description of performance, safety and longevity of Linox ICD leads published to date
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 the above point
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 centers, 75 active
Sample Size
  • 1,999 patients
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
  • Presence of another life-threatening, underlying illness separate from their cardiac disorder
  • Pregnancy
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
Devices
  • Linox and Linoxsmart ICD lead systems in conjunction with a BIOTRONIK ICD
Follow-Up
  • At least once every 6 months per site's institutional standard of care
Study Duration
  • January 2009 - November 2016
Reference no.
  • NCT00836589

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Long-Term Evaluation of Biotronik Linox and Linoxsmart Implantable Cardioverter Defibrillator Leads

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1 Good ED, Cakulev I, Orlov MV, Hirsh D, Similes J, Mohr K, Moll P, Bloom H; Long-Term Evaluation of Biotronik Linox and Linoxsmart Implantable Cardioverter Defibrillator Leads; J Cardiovasc Electrophysiol 2016 [epub]; DOI: 10.1111/jce.12971