CELESTIAL Post Approval Registry

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


Study Design

  • Multi-center, prospective, non-randomized, 5-year data collection registry
  • Designed to gather long-term safety and reliability data on BIOTRONIK’s Corox BP LV leads
  • 2,499 subjects at 97 US sites

Reference No.
  • NCT00810264
Study Objective
  • To confirm the long-term safety and successful biventricular pacing for BIOTRONIK's Corox BP left ventricular (LV) pacing leads as used in conjunction with any BOTRONIK CRT pulse generator (CRT pacemaker (CRT-P) or CRT defibrillator (CRT-D)).
1° Endpoints
  • Primary Endpoint 1 - to evaluate the overall incidence of serious adverse events (SAEs) related to the Corox BP LV leads
  • Primary Endpoint 2 - to evaluate the incidence of each type of serious adverse event that contributes to Primary Endpoint 1
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
  • Ventricular tachyarrhythmia conversion efficacy of the ICD shock therapy
Clinical Sites
  • 97 US sites
Sample Size
  • 2,499 subjects
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
  • Inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant
  • Corox OTW BP, Corox OTW-S BP, Corox OTW-L BP
  • Leads must be used in conjunction with a BIOTRONIK CRT-P or CRT-D
  • At least once every 6 months per site's institutional standard of care.
Study Duration
  • Study start date December 2008. Estimated study completion October 2018.