CVRx Inc. (NASDAQ: CVRX) announced the enrollment of the first patient in its BENEFIT-HF clinical trial at North Central Heart in Sioux Falls, South Dakota. Dr. Orvar Jonsson performed the enrollment at the Avera Heart Hospital division.

The trial aims to enroll 2,500 patients across approximately 150 centers in the United States and Germany. The study will evaluate CVRx's Barostim device in measuring all-cause mortality and heart failure decompensation events in an expanded heart failure patient population.

BENEFIT-HF is designed as a prospective, randomized, controlled, multicenter trial with CMS Category B IDE coverage. The trial is expected to continue through 2032 and represents one of the largest therapeutic cardiac device trials in heart failure.

"This study will evaluate Barostim therapy in a broader population of patients who remain symptomatic despite optimized guideline-directed medical therapy," said Dr. Jonsson.

Barostim is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery wall. The therapy aims to restore balance to the autonomic nervous system to reduce heart failure symptoms. The device has FDA approval for heart failure patients in the United States and CE Mark approval for heart failure and resistant hypertension in the European Economic Area.

CVRx stated that successful trial results could expand the indicated patient population for Barostim by approximately three times. The company manufactures neuromodulation solutions for cardiovascular diseases and received FDA Breakthrough Device designation for Barostim.