GALAXY: Long-Term Evaluation of the Linox Family ICD Leads Registry
Description of Research
The purpose of this study is to look at the long term safety and effectiveness of the current Biotronik ICD Lead, the Linox, a non-investigational lead. In this study, data will be collected on the leads that connect the ICD system to the heart. These leads are legally marketed in the United States and are not investigational products. The study Sponsor, BIOTRONIK, will collect additional long-term data on these leads. The study involves collection and analysis (testing) of data at regular follow-up visits with the participants' doctor. These follow up visits with their doctor are no different than would otherwise occur if they did not enroll in this study.
Study Number
HSR-09-1063
Inclusion/Notes
Participants have received an implantable cardioverter-defibrillator (ICD) system for the treatment of potentially fast heart rhythms. Their study doctor used the Linox lead as a part of their ICD system.
