BIO-LIBRA Clinical Study
The purpose of this registry is to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the primary prevention of sudden cardiac death. Differences in outcomes will be evaluated by sex and by device type.
• Patient meets current guideline-defined indication for de novo, primary prevention ICD or CRT-D implantation
• 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 able to understand the nature of the study and provide informed consent
• Patient is available for standard of care follow-up visits to occur at least yearly at the study site for to the expected 3 years of follow-up
• Patient is willing to utilize BIOTRONIK Home Monitoring® via CardioMessenger
• Patient age is greater than or equal to 18 years