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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
Results First Posted : November 29, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Congestive Heart Failure Device: CRT Therapy - LV Lead Registry

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 Design
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Study Type : Observational
Actual Enrollment : 2499 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CELESTIAL Post Approval Registry: Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry
Study Start Date : December 2008
Actual Primary Completion Date : November 2, 2018
Actual Study Completion Date : November 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort Intervention/treatment
Data Collection Group Device: CRT Therapy - LV Lead Registry
Collecting long-term safety and efficacy data on a market-released left ventricular lead.


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. Percentage of Subjects Experiencing Individual Complications [ Time Frame: 5 years ]
    Evaluation of the individual types of serious adverse events contributing to primary outcome 1.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810264


Locations
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Sponsors and Collaborators
Biotronik, Inc.
  Study Documents (Full-Text)

Documents provided by Biotronik, Inc.:
Study Protocol  [PDF] November 16, 2010
Statistical Analysis Plan  [PDF] April 26, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00810264    
Other Study ID Numbers: CELESTIAL
First Posted: December 18, 2008    Key Record Dates
Results First Posted: November 29, 2019
Last Update Posted: November 29, 2019
Last Verified: November 2019
Keywords provided by Biotronik, Inc.:
Long-term safety and reliability of a bipolar left ventricular lead on congestive heart failure patients
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases