Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure

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

First listed

Nov 18, 2025

Start date

Apr 24, 2026

Status verified

Sep 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 ]

Central Contacts

• Christina Dierkhising
  +1 763-416-2870
  [email protected]

Locations (14)

Find similar trials in Mobile, AL

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