The first two patients have been treated with CVRx’s Barostim Neo system in the Baroreflex Activation Therapy for Heart Failure pivotal clinical trial (BEAT-HF). The procedures were done at the University of California San Francisco (San Francisco, USA) and Arizona Heart Rhythm Research Center (Phoenix, USA). More than 20 patients have been enrolled and are being evaluated for eligibility.
BEAT-HF is a phase III randomised, controlled clinical trial studying the safety and efficacy of Barostim Therapy. Barostim is designed to simultaneously reduce sympathetic nervous system activity while restoring parasympathetic activity, for the treatment of heart failure. The trial will randomise 480 patients who suffer from heart failure with a reduced ejection fraction and who have no additional treatment alternatives available. BEAT-HF has achieved Expedited Access Pathway (EAP) designation by the US Food and Drug Administration for its focus on this unmet clinical need.
“We are very excited by the enrollment and treatment of the first patients in the BEAT-HF pivotal clinical trial. The patients we are including suffer from a very poor quality of life and an increased risk of heart failure-related hospitalisations, and they have no further treatment options,” saysMichael Zile, professor of Medicine at the Medical University of South Carolina and chair of the BEAT-HF Executive Steering Committee. “Barostim Therapy has already demonstrated symptom improvement through HOPE4HF, a Phase II randomised, controlled clinical trial, and we are looking forward to similar patient outcomes during BeAT-HF,” he says.