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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/21/2018
Start Date:December 2008
End Date:November 2, 2018

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

The objective of this study is to confirm the long-term safety and reliability of the Corox
OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a
registry documenting the post approval clinical experience of these leads be designed and
implemented.

This study is an FDA-required, multi-center, prospective, non-randomized, data collection
registry. Eligible patients must have been successfully implanted with a Corox OTW BP, Corox
OTW-S BP, or Corox OTW-L BP LV lead with a BIOTRONIK CRT device and consented and enrolled
between 7-180 days following implant. At least 2500 patients will be enrolled in this
post-approval registry, and each patient will be followed for five years post-implant.

Safety will be evaluated based on the analysis of the overall incidence of lead-related
adverse events that require additional invasive intervention. In addition, each individual
adverse event will be separately investigated. Lead parameters for sensing, pacing
thresholds, and impedance will also be evaluated. Reporting of all adverse events will be
performed twice a year in order to identify and characterize any trends in adverse events,
failure modes, or failure rates.

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

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
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