Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY) (GALAXY)
|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: NCT00836589|
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : February 20, 2017
|Condition or disease||Intervention/treatment|
|Patients Indicated for an ICD||Device: ICD Therapy - ICD Lead Registry|
This study is a multi-center, prospective, non-randomized, 5-year data collection registry. Eligible patients must have been successfully implanted with a Linox Lead System connected to a BIOTRONIK ICD and consented and enrolled between 1-45 days following implant. This study is designed to be a post-implant (office-based) registry, and patients are meant to be seen according to each institution's standard of care, but not to exceed a follow-up time frame of every 6 months. At least 2000 patients will be enrolled in this 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 to resolve. In addition, each individual adverse event will be separately investigated. Lead parameters for sensing, pacing thresholds, and impedance will also be evaluated. An independent Clinical Events Committee will review and adjudicate all adverse events that occur during the study according to the protocol definitions.
|Study Type :||Observational|
|Actual Enrollment :||1997 participants|
|Official Title:||GALAXY Registry: Long-term Evaluation of the Linox Family ICD Leads Registry|
|Study Start Date :||December 2008|
|Primary Completion Date :||December 2016|
|Study Completion Date :||December 2016|
|Data Collection Group||
Device: ICD Therapy - ICD Lead Registry
Collecting long-term safety and efficacy data on a family of market-released ICD leads.
- Overall complication-free rate [ 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): NCT00836589
Show 85 Study Locations