CELESTIAL

CELESTIAL Post Approval Registry

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

NCT00810264

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
Devices	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
Follow-Up	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.