NCT07335510

Impact of Barostimulation on Hemodynamics in Adults With Heart Failure

Impact of Barostimulation in Cardiac Hemodynamics and Clinical Outcomes Through Use of the Barostim™ CVRx Device

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Heart failure with reduced ejection fraction (HFrEF) remains a major public health concern, associated with high rates of morbidity, hospitalizations, and mortality. Despite advances in medication, as well as device therapies such as implantable devices, a significant proportion of patients continue to experience debilitating symptoms, exercise intolerance, and reduced quality of life. An important feature of HFrEF is autonomic imbalance, which contributes to disease progression and adverse outcomes. While current therapies indirectly try to affect this imbalance, the Barostim™ device (CVRx) is the first to specifically target the autonomic nervous system in this population. This device offers a novel mechanistic approach by directly stimulating the carotid baroreceptors to reduce sympathetic activity and restore autonomic balance. This prospective multicenter study aims to evaluate the effects of the Barostim device on invasive hemodynamics through right heart catheterization (RHC), exercise capacity, and tolerance to medical therapy in HFrEF patients who remain symptomatic despite maximal guideline-directed medical therapy (GDMT). The study seeks to address key knowledge gaps in the mechanistic and clinical response to baroreflex activation therapy (BAT) and inform future integration of this therapy into standard heart failure care.

Conditions

• HFrEF - Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
DEVICE	Baroreflex Activation Therapy	Barostim™ device (CVRx Inc.), a commercially available, FDA-approved device for autonomic modulation in HFrEF. The device system includes an implantable pulse generator, carotid sinus lead, and programmer system. No investigational modifications will be made. The device will be implanted per standard labeling and programming guidelines, and therapy titration will follow manufacturer recommendations.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study