Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure

Part of paid clinical trials in Mobile, Alabama.

Sponsor
CVRx, Inc.
Study ID
NCT07232030
Status
Enrolling By Invitation

Conditions

  • Heart Failure
  • Heart Failure NYHA Class II
  • Heart Failure NYHA Class III

Eligibility Criteria

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

Interventions

  • Barostim System — DEVICE
    Baroreflex Activation Therapy (BAT) using the Barostim System
  • Usual care medical management — OTHER
    Usual care medical management alone - no device implant

Study Details

The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in participants with heart failure, defined as NYHA Functional Class II or III, LVEF \< 50% and NT-proBNP \< 5,000 pg/mL despite being treated with Guideline-Directed Medical Therapies (medications and devices). It includes demonstration that treatment with the Barostim System, relative to usual care medical management, reduces the rate of all-cause mortality and Heart Failure Morbidity (Cardiac Transplant, Durable LVAD, or Worsening Heart Failure Events).

Key Dates

Start date
Apr 24, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2033
Completion
Jan 31, 2033

Study Design

Enrollment
2,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Device Arm
    Participants will receive Baroreflex Activation Therapy (BAT) with an implanted Barostim System in addition to usual care medical management.
  • Active Comparator: Control Arm
    Participants will receive usual care medical management alone with no Barostim System device implant.

Primary Outcome Measure

Primary Effectiveness Endpoint [ Time Frame: Through 24-months follow-up ]

Locations (4)

FacilityCityStateZIPSite coordinators
Cardiology Associates of MobileMobileAlabama36608-
Tallahassee Research InstituteTallahasseeFlorida32308-
BayCare Health SystemsTampaFlorida33614-
North Central HeartSioux FallsSouth Dakota57108-

Find similar trials in Mobile, AL

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Cardiology Associates of Mobile· Mobile, ALTallahassee Research Institute· Tallahassee, FLBayCare Health Systems· Tampa, FLNorth Central Heart· Sioux Falls, SD

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