NCT00810264

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,499 (actual)
• Sponsor: Biotronik, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
DEVICE	CRT Therapy - LV Lead Registry	Collecting long-term safety and efficacy data on a market-released left ventricular lead.

Timeline

• Start date: 2008-12-01
• Primary completion: 2018-11-02
• Completion: 2018-11-02
• First posted: 2008-12-18
• Last updated: 2019-11-29
• Results posted: 2019-11-29

Locations

86 sites across 1 country: United States