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BIO-LIBRA Clinical Study (BIO-LIBRA)

Analysis of Both Sex and Device Specific Factors on Outcomes in Patients With Non-Ischemic Cardiomyopathy

Overview

Overview

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

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

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
Learn More

Learn More

To learn more, visit ClinicalTrials.Gov

Study Type

Observational

Sponsor(s)

Biotronik, Inc.

Contact Us

Contact Us

To participate in this study, please contact Darla Howard at
864-560-1042