Biotronik said today that it launched enrollment in what it claims to be the first large-scale prospective study exploring sex-specific outcomes in patients with non-ischemic cardiomyopathy treated with a cardiac defibrillator.
The newly launched BIO-LIBRA study aims to enroll up to 1,000 patients, with a minimum of 40% female enrollment, and will explore whether women and men respond differently to defibrillator therapy.
“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. The study will emphasize enrollment of women to fill the gap that currently exists in our knowledge of ICD effectiveness between sexes,” principal investigator Dr. Valentina Kutyifa of New York’s University of Rochester Medical Center said in prepared remarks.
“Not only will the BIO-LIBRA study enroll a large number of female patients, it is also led by female physicians. 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,” co-principal investigator Jeanne Poole of Seattle’s University of Washington said in a prepared statement.
Patients in the trial will be treated with a Biotronik implantable cardioverter defibrillator or a cardiac resynchronization therapy defibrillator device, the Germany-based company said. Study investigators will analyze combined risk of all-cause mortality and treated ventricular tachycardia and ventricular fibrilation by both device type and sex, Biotronik added.
“At Biotronik, our priority is innovation that matters. We develop groundbreaking technologies that positively impact cardiac patient populations that are often overlooked. This study is an example of how we are investing in research that ensures all patients receive the best care possible,” Biotronik prez Ryan Walters said in a press release.
Last month, Biortonik said that it’s launching the PK Papyrus covered coronary stent system for acute coronary artery perforations in the U.S.
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