Clinical Trial

Impact of Barostimulation on Hemodynamics in Adults With Heart Failure

Study acronym: BREATHE-HF
Recruiting
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Summary
This study evaluates the effects of the implantation and adjustment of the CVRx Barostim device in adult patients with heart failure with reduced ejection fraction who are receiving maximally tolerated doses of guideline directed medical and device therapies. The study aims to assess how therapy using this device affects heart function, symptoms, and exercise capacity, with particular focus on how the device affects blood flow and heart pressures during exercise. Information from this study may help inform patient selection and device management in patients with heart failure.
Protocol Amendment History 1 change
critical Recruitment opened 2026-06-30
Trial Details
NCT Number NCT07335510
Lead Sponsor Columbia University
Collaborators: CVRx, Inc.
Conditions HFrEF - Heart Failure With Reduced Ejection Fraction
Enrollment 58 participants
Start Date 2026-03-30
Primary Completion 2027-12 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-29