Overview

• The BIO-LIBRA trial enrolled 1,000 patients with non-ischemic cardiomyopathy who received either an ICD or a CRT‑D.
• At one year, the composite of death or life‑threatening ventricular arrhythmia occurred in 13% of participants assigned male at birth versus 6% of those assigned female at birth.
• Investigators report this is the first device study with sufficient female enrollment to demonstrate a statistically and clinically meaningful sex-based difference.
• Pragmatic measures—coordinating study visits with routine care, remote monitoring, broad eligibility, and staff education—helped achieve about 48% female enrollment.
• The study remains active with planned three‑year follow‑up to validate durability of the findings, and the research was reported as funded by BIOTRONIK.