Clinical TrialMay 4, 2026, 04:32 PM
CVRx enrolls first patient in landmark BENEFIT-HF trial
AI Summary
CVRx, Inc. announced the enrollment of the first patient in its landmark BENEFIT-HF trial at North Central Heart. This prospective, randomized, controlled, multicenter trial is expected to be one of the largest therapeutic cardiac device trials ever performed in heart failure, aiming to enroll 2,500 patients across approximately 150 centers in the United States and Germany. The trial, supported by CMS Category B IDE coverage, will evaluate Barostim therapy in a broader heart failure population and, if successful, could expand the indicated patient population for Barostim by approximately three times, significantly broadening access to the therapy. The trial is expected to continue through 2032.
Key Highlights
- First patient enrolled in the landmark BENEFIT-HF trial at North Central Heart.
- Trial to enroll 2,500 patients at approximately 150 centers in the US and Germany.
- Designed to evaluate all-cause mortality and heart failure decompensation events.
- Expected to continue through 2032.
- Potential to expand Barostim's indicated patient population by approximately three times.