CVRx reports preliminary results of BeAT-HF post-market clinical trial

CVRx announced the preliminary topline results of the BeAT-HF, Baroreflex Activation Therapy for Heart Failure, post-market randomized clinical trial. The BeAT-HF post-market phase of the multi-center, prospective, randomized, controlled trial assessed 323 patients suffering from heart failure with reduced ejection fraction. The primary endpoint was a composite of cardiovascular mortality and heart failure morbidity. While the trial did not reach statistical significance on the primary endpoint, it did contain additional clinically meaningful prespecified analyses that favored Barostim, including: all-cause survival, free from LVAD and heart transplant; a hierarchical composite analysis of cardiovascular mortality, heart failure events and quality of life; and a clinical stability analysis. In addition, the safety profile of Barostim and the symptomatic improvement at 6 months, that were the basis for the FDA pre-market approval, were shown to be durable through 24 months. "We are grateful to all the patients who enrolled in BeAT-HF, to the investigators in the 108 clinical sites and to the Executive Steering Committee for their dedicated effort over the years," said Nadim Yared, President and CEO of CVRx. "This new evidence is welcome news for the many patients with heart failure, who remain symptomatic despite optimal medical therapy. We plan to submit the totality of evidence of BeAT-HF to FDA seeking an expansion of Barostim labeling."