Trial record 1 of 3 for:    CELESTIAL
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Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar (CELESTIAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT00810264
First received: December 17, 2008
Last updated: October 16, 2013
Last verified: October 2013

December 17, 2008
October 16, 2013
December 2008
December 2018   (final data collection date for primary outcome measure)
Overall complication-free rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00810264 on ClinicalTrials.gov Archive Site
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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

The objective of this study is to confirm the long-term safety and reliability of the Corox OTW(-S) 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(-S) BP LV lead with a BIOTRONIK CRT device and consented and enrolled between 7-180 days following implant. At least 2000 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients will be obtained from the investigators' general patient population according to the inclusion and exclusion criteria described below.

Congestive Heart Failure
Device: CRT Therapy - LV Lead Registry
Collecting long-term safety and efficacy data on a market-released left ventricular lead.
Data Collection Group
Intervention: Device: CRT Therapy - LV Lead Registry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2500
December 2018
December 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Successfully implanted BIOTRONIK CRT system, including a Corox OTW(-S) 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00810264
CELESTIAL
No
Biotronik, Inc.
Biotronik, Inc.
Not Provided
Not Provided
Biotronik, Inc.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP