Impact of Barostimulation on Hemodynamics in Adults With Heart Failure

NCT ID: NCT07335510

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-03-31

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.

Detailed Description

Heart failure with reduced ejection fraction (HFrEF) remains a major public health concern, associated with high rates of morbidity, hospitalizations, and mortality. Despite advances in medication, as well as device therapies such as implantable devices, a significant proportion of patients continue to experience debilitating symptoms, exercise intolerance, and reduced quality of life.

An important feature of HFrEF is autonomic imbalance, which contributes to disease progression and adverse outcomes. While current therapies indirectly try to affect this imbalance, the Barostim™ device (CVRx) is the first to specifically target the autonomic nervous system in this population. This device offers a novel mechanistic approach by directly stimulating the carotid baroreceptors to reduce sympathetic activity and restore autonomic balance. This prospective multicenter study aims to evaluate the effects of the Barostim device on invasive hemodynamics through right heart catheterization (RHC), exercise capacity, and tolerance to medical therapy in HFrEF patients who remain symptomatic despite maximal guideline-directed medical therapy (GDMT). The study seeks to address key knowledge gaps in the mechanistic and clinical response to baroreflex activation therapy (BAT) and inform future integration of this therapy into standard heart failure care.

Conditions

HFrEF - Heart Failure With Reduced Ejection Fraction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Baroreflex Activation Therapy

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CVRx, Inc.

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Nir Uriel

Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nir Uriel, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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

Countries

United States

Central Contacts

Morgan Smith, MD

Role: CONTACT

mds2225@cumc.columbia.edu

914-629-3121

Facility Contacts

Liviu Klein, MD

Role: primary

liviu.klein@ucsf.edu

415-353-2873

Farooq H. Sheikh, MD

Role: primary

farooq.h.sheikh@medstar.net

202-877-4698

Manreet Kanwar, MD

Role: primary

manreetkanwar@uchicago.edu

773-702-9461

Maria Karas, MD

Role: primary

mgk2002@med.cornell.edu

646-962-5555

Gabriel T. Sayer, MD

Role: primary

gts2102@cumc.columbia.edu

212-342-3259

Ulrich P. Jorde, MD

Role: primary

ujorde@montefiore.org

718-920-2626

Ryan J. Tedford, MD

Role: primary

tedfordr@musc.edu

843-792-1952

References

Zile MR, Lindenfeld J, Weaver FA, Zannad F, Galle E, Rogers T, Abraham WT. Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2020 Jul 7;76(1):1-13. doi: 10.1016/j.jacc.2020.05.015.

Reference Type: BACKGROUND

PMID: 32616150 (View on PubMed)

Coats AJS, Abraham WT, Zile MR, Lindenfeld JA, Weaver FA, Fudim M, Bauersachs J, Duval S, Galle E, Zannad F. Baroreflex activation therapy with the Barostim device in patients with heart failure with reduced ejection fraction: a patient level meta-analysis of randomized controlled trials. Eur J Heart Fail. 2022 Sep;24(9):1665-1673. doi: 10.1002/ejhf.2573. Epub 2022 Jul 3.

Reference Type: BACKGROUND

PMID: 35713888 (View on PubMed)

Related Links

https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180050b.pdf

Summary of Safety and Effectiveness Data (SSED; FDA)

Other Identifiers

AAAV9622

Identifier Type: -

Identifier Source: org_study_id