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Impact of Barostimulation on Hemodynamics in Adults With Heart Failure
Sponsor: Columbia University
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.
Official title: Impact of Barostimulation in Cardiac Hemodynamics and Clinical Outcomes Through Use of the Barostim™ CVRx Device
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2026-01
Completion Date
2028-03
Last Updated
2026-01-13
Healthy Volunteers
No
Interventions
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.
Locations (7)
University of California San Francisco Health
San Francisco, California, United States
MedStar Health
Washington D.C., District of Columbia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Weill Cornell Medicine
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
Medical University of South Carolina Health
Charleston, South Carolina, United States