Impact of Barostimulation on Hemodynamics in Adults With Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About 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.
Eligibility criteria
Qualifiers
Diagnosis of heart failure with reduced ejection fraction (defined as ejection fraction ≤ 35% for the purposes of this study) (should be within 12 months of screen)
current New York Heart Association (NYHA) Class III or
current NYHA Class II and historical NYHA Class III
Laboratories with last N-terminal pro-B-type natriuretic peptide (NT-proBNP) < 1600 pg/ml (should be within 3 months of screen)
Disqualifiers
Age < 18 years
Myocardial infarction (MI), syncope, cerebrovascular accident (CVA), aborted sudden cardiac death (SCD) (and implantable cardioverter defibrillator (ICD) therapy) within 3 months of screening
Bilateral carotid bifurcations located above the level of the mandible
Carotid artery stenosis greater than 50% caused by atherosclerosis
Trial design
Treatments tested in this trial
- Baroreflex Activation Therapy
Treatment groups
58 Participants
are divided into 1 treatment groupSponsors and collaborators
Columbia University
Lead sponsor
CVRx, Inc.
Collaborator
Source ClinicalTrials.gov