Recruiting

CVRx Barostim

Sponsor:

Columbia University

Code:

NCT07335510

Conditions

HFrEF - Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Baroreflex Activation Therapy

Study Details

Brief 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.

Conditions

HFrEF - Heart Failure With Reduced Ejection Fraction

Study ID

NCT07335510

Start date

Mar 30, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)
  • Symptoms consistent with one of:

1. current New York Heart Association (NYHA) Class III or
2. 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)
  • Management with maximally-tolerated GDMT medications and devices
  • Age >= 18 years

Exclusion Criteria:

  • 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
  • Ulcerative plaques in the carotid artery
  • Baroreflex failure or autonomic neuropathy
  • Symptomatic un-controlled bradyarrhythmias
  • Severe chronic lung disease
  • Current treatment with inotropes
  • Pacemaker or ICD within 3 months of screening
  • Cardiac resynchronization therapy (CRT) devices within 6 months of screening or anticipated to be placed in the next 90 days following screening
  • Prior surgery, radiation, endovascular stent in the carotid sinus
  • History or consideration of solid organ transplantation
  • History or consideration of left ventricular assist device (LVAD)
  • Life expectancy <1 year from time of screening
  • Non-cardiovascular conditions interfering with 6MWT distance assessment
  • Inability to fulfill protocol requirements
  • Known allergy to silicone or titanium

Study Design

Enrollment

58 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Barostim™ Therapy

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.

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.

Primary outcome measure

  • Change in peak exercise PCWP at 6 months post-titration [ Time Frame: Pre-implantation phase (baseline, 0-2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation). ]

Central Contacts and Locations

Central contacts

Morgan Smith, MD

914-629-3121mds2225@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Gabriel T. Sayer, MD

212-342-3259gts2102@cumc.columbia.edu

Principal Investigator:

Nir Uriel, MD

More Information

Sponsor

Columbia University

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Baroreflex activation therapy
  • Exercise hemodynamics
  • Barostim
  • Cardiopulmonary exercise testing
  • Neuromodulation
  • Functional capacity
  • Heart failure with reduced ejection fraction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-06-29.