CELESTIAL

CELESTIAL Post Approval Registry

Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry

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Study Design

  • Multi-center , prospective, non-randomized, FDA reviewed, observational study1
  • Designed to gather long-term safety and reliability data on BIOTRONIK’s Corox BP LV leads
  • 2,499 patients at 97 USA centers. This study is ongoing, but enrollment is complete

Key Result

The CELESTIAL registry focuses primarily on the performance of Corox leads (n=2,499), however, the majority of patients received a CRT-D system including a Linox or Linoxsmart ICD lead (n=1,843) 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 AEs.
  • Estimated cumulative survival probability is favorable 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.
Reference no.
  • NCT00810264
1° Endpoints
  • To evaluate the overall incidence of serious adverse events related to the Corox BP LV leads
  • To evaluate the incidence of each type of serious adverse event that contributes to the above point
2° Endpoints
  • Successful biventricular pacing in a BIOTRONIK CRT device at scheduled CELESTIAL registry follow-up through 5 years post-enrollment
  • Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-enrollment
  • Pacing threshold, sensing, and impedance measurements for Corox BP leads at scheduled CELESTIAL registry follow-up through 5 years post-enrollment
Clinical Sites
  • 99 centers, 78 active
Sample Size
  • 2,499 patients
Inclusion Criteria
  • Successfully implanted BIOTRONIK CRT system, including a Corox BP LV lead, from 7-180 days prior to enrollment.
  • Able to understand the nature of the registry and give 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 interventional 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
  • Corox OTW BP, Corox OTW-S BP, Corox OTW-L BP in conjunction with a BIOTRONIK CRT-P or CRT-D

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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