To adequately analyze whether women and men respond differently to defibrillator therapy, a minimum of 40 percent female enrollment is targeted. BIO-LIBRA is a non-randomized observational study in the US only.

Heart disease is the leading cause of death in both women and men, yet previous cardiovascular device studies have lacked a proportionate representation of women.1 The BIO-LIBRA study aims to identify data that may enable altered device strategies between the sexes.

To do this, the BIO-LIBRA study will investigate sex-specific outcomes in patients with NICM treated with a BIOTRONIK implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) device, which will include the newest BIOTRONIK ICDs and CRT-Ds, Acticor and Rivacor. The study will analyze the combined risk of all-cause mortality and treated ventricular tachycardia (VT) and ventricular fibrillation (VF) by both device type and sex in up to 1,000 patients. The outcomes data will help determine the most effective therapies for future generations of women and men.

“BIO-LIBRA is a landmark clinical study that will balance our understanding of ventricular arrhythmia events and cause of death in patients with NICM treated with ICDs and CRT-Ds,” said Principal Investigator Dr. Valentina Kutyifa, Associate Professor of Medicine at the University of Rochester Medical Center, Rochester, NY. “The study will emphasize enrollment of women to fill the gap that currently exists in our knowledge of ICD effectiveness between sexes.”

Many treatment options offered today have not been studied in large cohorts of women, due to limited enrollment of women in clinical studies. The FDA has recognized the underrepresentation of women in cardiovascular studies, addressing the problem with guidance in 2014 that requests an adequate number of women are enrolled in cardiac device trials to accurately evaluate sex-specific outcomes.

“Not only will the BIO-LIBRA study enroll a large number of female patients, it is also led by female physicians,” said Co-Principal Investigator Jeanne Poole, Professor of Cardiology and Medicine at the University of Washington, Seattle, WA. “As a member of the Electrophysiologist International Community (EPIC) 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.”

Studies have also shown women are less fearful of heart disease compared to breast cancer, despite the fact that heart disease claims significantly more lives than breast cancer.2 The BIO-LIBRA study will increase awareness of heart disease in women while identifying better therapy solutions for those who suffer from heart disease.

“At BIOTRONIK, our priority is innovation that matters. We develop groundbreaking technologies that positively impact cardiac patient populations that are often overlooked,” said Ryan Walters, President of BIOTRONIK, Inc. “This study is an example of how we are investing in research that ensures all patients receive the best care possible.”

Source: Company Press Release.