The BENEFIT-HF trial is set to be among the most extensive therapeutic cardiac device trials conducted for heart failure, with a projected enrollment of 2,500 patients treated across approximately 150 medical centers located in the United States and Germany. This represents a major clinical initiative aimed at expanding therapeutic options for those suffering from heart failure.
The Barostim device, which attained FDA approval in 2019 under the Breakthrough Devices Program, is an implantable neuromodulation system that targets baroreceptors on the carotid artery by delivering electrical impulses to alleviate heart failure symptoms. The ongoing study plans to involve patients exhibiting a higher left ventricular ejection fraction than the population indicated in previous trials.
Philip Adamson, Chief Medical Officer of CVRx, remarked, "The BENEFIT-HF trial signifies an important progression in our approach to treating heart failure patients. Prior studies, such as the BeAT-HF trial, have demonstrated strong clinical benefits including improved symptoms and functional capacity within a targeted heart failure subgroup."
Furthermore, the Centers for Medicare & Medicaid Services (CMS) has granted Category B Investigational Device Exemption (IDE) coverage for the BENEFIT-HF trial, facilitating patient access to the device throughout the study duration. Should the trial prove successful, CVRx anticipates the indicated patient population eligible for Barostim therapy could increase roughly threefold.
Enrollment for the BENEFIT-HF trial is planned to commence in the first half of 2026. The primary endpoint of the study will be a composite measure encompassing all-cause mortality and events related to heart failure decompensation, underscoring the focus on both survival and disease management outcomes.