Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar (CELESTIAL)
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| First Received Date ICMJE | December 17, 2008 | ||||||||
| Last Updated Date | March 13, 2013 | ||||||||
| Start Date ICMJE | December 2008 | ||||||||
| Estimated Primary Completion Date | December 2018 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Overall complication-free rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00810264 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar | ||||||||
| Official Title ICMJE | 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(-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. |
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| 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(-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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| 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. |
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| Condition ICMJE | Congestive Heart Failure | ||||||||
| Intervention ICMJE | Device: CRT Therapy - LV Lead Registry
Collecting long-term safety and efficacy data on a market-released left ventricular lead. |
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| Study Group/Cohort (s) | Data Collection Group
Intervention: Device: CRT Therapy - LV Lead Registry |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 2500 | ||||||||
| Estimated Completion Date | December 2018 | ||||||||
| Estimated Primary Completion Date | December 2018 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00810264 | ||||||||
| Other Study ID Numbers ICMJE | CELESTIAL | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Biotronik, Inc. | ||||||||
| Study Sponsor ICMJE | Biotronik, Inc. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Biotronik, Inc. | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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