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NOT YET RECRUITING
NCT07335510
NA

Impact of Barostimulation on Hemodynamics in Adults With Heart Failure

Sponsor: Columbia University

View on ClinicalTrials.gov

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

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.

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