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  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
  • Healthy Volunteers


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.


The BIO-LIBRA Study will gather information about women and men with non-ischemic cardiomyopathy who are treated with implanted ICD and CRT-D devices from many locations across the United States. The BIO-LIBRA Study will look at the results of treatment in women and men enrollees. The two primary goals are: 1) to learn if there are differences in treatment response based on the patient's sex; and 2) to learn if there are differences in patient outcomes based on device type.

There is a special focus on women in the BIO-LIBRA Study. Usually, only about 25% of people in prior device studies have been women. Yet heart disease is the number-one cause of death for women * one in three deaths each year. The BIO-LIBRA Study would like to have a more balanced study which includes more women than in prior studies. The goal is for at least 40% of the people participating in the study to be women.

The study will observe up to 1,000 women and men over a three-year period following the device implant. Utilizing information collected at annual doctor visits and scheduled transmission reports from the implanted device in between these visits, the BIO-LIBRA Study will be able to evaluate some of the common risks of non-ischemic cardiomyopathy.


Full study title Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy
Protocol number OCR23962 ID NCT03884608


Inclusion Criteria:

  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

  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 CardioMessenger

  7. Patient age is greater than or equal to 18 years

Exclusion Criteria:

  1. Patient meets secondary prevention ICD indication

  2. Patient has ischemic etiology of cardiomyopathy

  3. Patient is enrolled in any investigational cardiac device or drug trial that might significantly affect the studied outcomes

  4. Patient is expected to receive heart transplantation or ventricular assist device within 1 year

  5. Patient life expectancy is less than 1 year

  6. Patient reports pregnancy at the time of consent

Lead researcher

  • Vilma Torres, MD, FACC, FHR
    Cardiologist (Heart Specialist), Clinical Cardiologist - Electrophysiology Specialist
    Languages: Spanish
    Vilma Torres

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step


    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.