Title: BIO-LIBRA Clinical Study
Description: This study is being conducted by BIOTRONIK in collaboration with the University of Rochester to better understand the outcomes of device-treated ventricular tachyarrhythmias (fast heart beats) and causes of death in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the primary prevention of sudden cardiac death.
The study involves collection and review of data at regular follow-up visits with your doctor. These follow-up visits with your doctor are no different than would otherwise occur if you did not enroll in this study.
4 Key Inclusion/Exclusion Criteria including Age Range If Applicable:
• Patient has non-ischemic etiology of cardiomyopathy
• Patient is successfully implanted with a de novo BIOTRONIK ICD or CRT-D device and commercially available leads no more than 30 days prior to consent or is scheduled for de novo implantation of a BIOTRONIK ICD or CRT-D device no more than 30 days post consent
• Patient is not enrolled in any investigational cardiac device or drug trial that might significantly affect the studied outcomes
• Patient is not expected to receive heart transplantation or ventricular assist device within 1 year