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

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.

Inclusion criteria

• 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

Exclusion criteria

• 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