Impact of Barostimulation on Hemodynamics in Adults With Heart Failure

NCT07335510 | Not Yet Recruiting FDA Device

• 1 other identifier: AAAV9622
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 7

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in peak exercise PCWP at 6 months post-titration

  Exercise pulmonary capillary wedge pressure (PCWP) will be measured at peak exercise at approximately six months post-Barostim titration and compared with peak exercise PCWP measured during the pre-implantation phase. Change from baseline will be calculated.

  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).

Secondary Outcomes (18)

• Change in peak exercise load-adjusted PCWP at 6 months post-titration

  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).

• Change in peak exercise output-adjusted PCWP at 6 months post-titration

  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).

• Change in peak exercise cardiac output at 6 months post-titration

  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).

• Proportion of participants with significant reduction in PCWP at 6 months post-titration

  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).

• Change in peak exercise mean PA pressures at 6 months post-titration

  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).

Other Outcomes (4)

• Correlate estimated peak VO2 by smartwatch to peak VO2 obtained via cardiopulmonary exercise testing

  Pre-implantation phase (baseline, approx. 2 months) and post-titration phase (approximately 6 months after completion of device titration, i.e. approx. 7-9 months post-implantation).

• Change in estimated peak VO2 by smartwatch after implantation over time

  Pre-implantation phase (baseline, 0-2 months) and post-implantation phase (approximately 0-9 months post-implantation) at regular intervals, e.g., monthly

• Change in clinically significant echocardiography parameters at 6 months post-titration

  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).

Study Arms (1)

Barostim™ Therapy

EXPERIMENTAL

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.

Device: Baroreflex Activation Therapy

Interventions

Baroreflex Activation Therapy 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.

Barostim™ Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)
• Management with maximally-tolerated GDMT medications and devices
• Age \>= 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• CVRx, Inc.: collaborator

Study Sites (7)

University of California San Francisco Health

San Francisco, California, 94143, United States

Location

MedStar Health

Washington D.C., District of Columbia, 20010, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 15212, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center

New York, New York, 10461, United States

Location

Medical University of South Carolina Health

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

• 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.

  PMID: 32616150 BACKGROUND

• 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.

  PMID: 35713888 BACKGROUND

Related Links

• Summary of Safety and Effectiveness Data (SSED; FDA)

Study Officials

• Nir Uriel, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgan Smith, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Model Details: This is a single-group, self-controlled study in which all enrolled participants receive the same intervention. Outcomes are evaluated within participants using pre- and post-implantation assessments following Barostim device implantation and titration.

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (7)