Biotronik is targeting a minimum of 40% female enrollment for its newest project, a large-scale prospective study of sex differences in patients with non-ischemic cardiomyopathy (NICM) and an implanted cardiovascular device.
Biotronik’s announcement of the BIO-LIBRA trial comes just a month after a trio of studies presented at the Heart Rhythm Society’s 40th annual scientific sessions revealed significant disparities in patient access to lifesaving devices like implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillator devices (CRT-Ds). In those analyses, women and black patients saw the lowest rates of device usage.
BIO-LIBRA will, according to Biotronik, investigate sex-specific outcomes in NICM patients treated with a Biotronik ICD or CRT-D and analyze the combined risk of all-cause mortality and treated ventricular tachycardia and ventricular fibrillation by device type and sex. The study is slated to enroll up to 1,000 patients.
“Not only will the BIO-LIBRA study enroll a large number of female patients, it is also led by female physicians,” co-principal investigator Jeanne Poole, a professor of cardiology and medicine at the University of Washington in Seattle, said in a release. “As a member of the Electrophysiologist International Community Alliance, advocating for women has been a continuous pursuit. Female physicians involved with BIO-LIBRA will play a pivotal role in its success and demonstrate a clear commitment to advancing healthcare for women.”