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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 : Active, not recruiting
First Posted : December 18, 2008
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

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 Type : Observational
Estimated Enrollment : 2500 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
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Overall complication-free rate [ Time Frame: 5 years ]
  2. Individual complication rates [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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


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Sponsors and Collaborators
Biotronik, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00810264     History of Changes
Other Study ID Numbers: CELESTIAL
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

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:
Heart Failure
Heart Diseases
Cardiovascular Diseases