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 : Active, not recruiting
First Posted : December 18, 2008
Last Update Posted : July 25, 2018
|Condition or disease||Intervention/treatment|
|Congestive Heart Failure||Device: CRT Therapy - LV Lead Registry|
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|
|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|
|Data Collection Group||
Device: CRT Therapy - LV Lead Registry
Collecting long-term safety and efficacy data on a market-released left ventricular lead.
- Overall complication-free rate [ Time Frame: 5 years ]
- Individual complication rates [ Time Frame: 5 years ]
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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