Baroreflex Activation Therapy for Heart Failure
(BREATHE-HF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Nir Uriel, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for adults with heart failure where the heart's pumping power is reduced (ejection fraction ≤ 35%). Participants must be on full doses of standard heart failure treatments, have a certain level of NT-proBNP (a heart stress marker), and fall within specific categories of symptom severity. People under 18 or those not meeting these criteria cannot join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation and Titration
Participants undergo implantation of the Barostim™ system, followed by device programming and titration
Post-Titration Monitoring
Participants are monitored for changes in cardiac output, PCWP, and other parameters approximately 6 months after device titration
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Baroreflex Activation Therapy
Trial Overview
The study tests Baroreflex Activation Therapy using the CVRx Barostim device in patients with severe heart failure. It looks at how this therapy affects their heart function, symptoms, and ability to exercise by monitoring blood flow and pressures during physical activity.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will undergo implantation of the Barostim™ system, followed by device programming and titration according to standard clinical practice for up to three months after implantation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
CVRx, Inc.
Industry Sponsor
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