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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00810264
Recruitment Status : Completed
First Posted : December 18, 2008
Results First Posted : November 29, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

Tracking Information
First Submitted Date December 17, 2008
First Posted Date December 18, 2008
Results First Submitted Date October 8, 2019
Results First Posted Date November 29, 2019
Last Update Posted Date November 29, 2019
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: November 11, 2019)
  • Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead [ Time Frame: 5 years ]
    The overall incidence of serious adverse events that require additional invasive intervention to resolve, related to the Corox BP LV leads implanted with either BIOTRONIK CRT-P or CRT-D devices.This was evaluated as a serious adverse event free-rate (SAEFR).
  • Percentage of Subjects Experiencing Individual Complications [ Time Frame: 5 years ]
    Evaluation of the individual types of serious adverse events contributing to primary outcome 1.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: November 11, 2019)
  • Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit. [ Time Frame: 5 years ]
    Successful biventricular pacing in a BIOTRONIK CRT device at scheduled CELESTIAL registry follow-up visits through 5 years post-implant.
  • Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint [ Time Frame: 5 years ]
    Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-implant.
  • Corox BP LV Lead Pacing Threshold Measurements [ Time Frame: 5 years ]
    Pacing threshold measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
  • Corox BP LV Lead Sensing Measurements [ Time Frame: 5 years ]
    Sensing measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
  • Corox BP LV Lead Impedance Measurements [ Time Frame: 5 years ]
    Impedance measurements for the all Corox BP LV lead models at scheduled CELESTIAL registry through 5 years post-implant.
  • Pacing Threshold Measurements Per Corox BP LV Lead Model [ Time Frame: 5 years ]
    Pacing threshold measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.
  • Sensing Measurements Per Corox BP LV Lead Model [ Time Frame: 5 years ]
    Sensing measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.
  • Impedance Measurements Per Corox BP LV Lead Model [ Time Frame: 5 years ]
    Impedance measurements for the Corox OTW BP LV lead, the Corox OTW-S BP LV lead, and the Corox OTW-L BP LV lead.
  • Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model [ Time Frame: 5 years ]
    Overall incidence of serious adverse events that meet the primary endpoint 1 criteria will be evaluated separately for each Corox BP lead model.
  • Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model [ Time Frame: 5 years ]
    Incidence of individual types of serious adverse events contributing to primary endpoint 2 will be evaluated separately for each Corox BP lead model.
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 November 2019