BIO-LIBRA Clinical Study (BIO-LIBRA)
Analysis of Both Sex and Device Specific Factors on Outcomes in Patients With Non-Ischemic Cardiomyopathy
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.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- 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
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- Patient meets secondary prevention ICD indication
- Patient has ischemic etiology of cardiomyopathy
- Patient is enrolled in any investigational cardiac device or drug trial that might significantly affect the studied outcomes
- Patient is expected to receive heart transplantation or ventricular assist device within 1 year
- Patient life expectancy is less than 1 year
- Patient reports pregnancy at the time of consent
To learn more, visit ClinicalTrials.Gov