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

Biotronik

Status: Completed

Conditions: Congestive Heart Failure

Treatments: Device: CRT Therapy - LV Lead Registry

Study type: Observational

Funder types: Industry

Identifiers

NCT00810264

CELESTIAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,499 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,499 participants in 1 patient group

Data Collection Group

Treatment:

Device: CRT Therapy - LV Lead Registry