BIO-LIBRA

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

  • Clinical Trial Information

    Trial Contact: Peisner, Pamela

    Trial Phone: 321.843.1037

  • IRB No: 19.209.07

    Protocol Abbrev: Bio-Libra

    Principal Investigator: Luis Isaac Garcia, MD

    Age Group: Adult

    ClinicalTrials.gov ID: 03884608

  • Objective

    The primary objective of this study is to evaluate the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events by subject sex and by implanted device type.

  • Key Eligibility

    1. Patient meets current guideline-defined indication for de novo, primary prevention ICD or CRT-D implantation
    2. Patient has non-ischemic etiology of cardiomyopathy ii
    3. 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
    4. Patient is able to understand the nature of the study and provide informed consent
    5. 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
    6. Patient is willing to utilize BIOTRONIK Home Monitoring® via CardioMessengeriii
    7. Patient age is greater than or equal to 18 years