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

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ClinicalTrials.gov Identifier: NCT00810264
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

Tracking Information
First Submitted Date December 17, 2008
First Posted Date December 18, 2008
Last Update Posted Date December 19, 2018
Study Start Date December 2008
Actual Primary Completion Date November 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2016)
  • Overall complication-free rate [ Time Frame: 5 years ]
  • Individual complication rates [ Time Frame: 5 years ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00810264 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar
Official Title CELESTIAL Post Approval Registry: Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry
Brief 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients will be obtained from the investigators' general patient population according to the inclusion and exclusion criteria described below.
Condition Congestive Heart Failure
Intervention Device: CRT Therapy - LV Lead Registry
Collecting long-term safety and efficacy data on a market-released left ventricular lead.
Study Groups/Cohorts Data Collection Group
Intervention: Device: CRT Therapy - LV Lead Registry
Publications * Good ED, Cakulev I, Orlov MV, Hirsh D, Simeles J, Mohr K, Moll P, Bloom H. Long-Term Evaluation of Biotronik Linox and Linox(smart) Implantable Cardioverter Defibrillator Leads. J Cardiovasc Electrophysiol. 2016 Jun;27(6):735-42. doi: 10.1111/jce.12971. Epub 2016 May 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 17, 2018)
2499
Original Estimated Enrollment
 (submitted: December 17, 2008)
2000
Actual Study Completion Date November 2, 2018
Actual Primary Completion Date November 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00810264
Other Study ID Numbers CELESTIAL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biotronik, Inc.
Study Sponsor Biotronik, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Biotronik, Inc.
Verification Date December 2018