Impact of Barostimulation on Hemodynamics in Adults With Heart Failure

Part of paid clinical trials in San Francisco, California.

Sponsor
Columbia University
Study ID
NCT07335510
Status
Not Yet Recruiting

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Conditions

  • HFrEF - Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
58 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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

Locations (7)

FacilityCityStateZIPSite coordinators
University of California San Francisco HealthSan FranciscoCalifornia94143
Liviu Klein, MD
[email protected]
415-353-2873
Liviu Klein, MD (PRINCIPAL_INVESTIGATOR)
MedStar HealthWashington D.C.District of Columbia20010
Farooq H. Sheikh, MD
[email protected]
202-877-4698
Farooq H. Sheikh, MD (PRINCIPAL_INVESTIGATOR)
Richa Gupta, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago Medical CenterChicagoIllinois15212
Manreet Kanwar, MD
[email protected]
773-702-9461
Manreet Kanwar, MD (PRINCIPAL_INVESTIGATOR)
Mark Belkin, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Gabriel T. Sayer, MD
[email protected]
212-342-3259
Nir Uriel, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterNew YorkNew York10461
Ulrich P. Jorde, MD
[email protected]
718-920-2626
Ulrich P. Jorde, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10021
Maria Karas, MD
[email protected]
646-962-5555
Maria Karas, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South Carolina HealthCharlestonSouth Carolina29425
Ryan J. Tedford, MD
[email protected]
843-792-1952
Ryan J. Tedford, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California San Francisco Health· San Francisco, CAMedStar Health· Washington D.C., DCUniversity of Chicago Medical Center· Chicago, ILColumbia University Irving Medical Center· New York, NYMontefiore Medical Center· New York, NYWeill Cornell Medicine· New York, NY

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