Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure (NCT07232030) | Clinical Trial Compass
By InvitationNot Applicable
Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
United States2,500 participantsStarted 2026-04
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 years or above
✓. NYHA Functional Class II or III heart failure symptoms at the time of screening
✓. Left ventricular ejection fraction \< 50% within 6 months of consent
✓. Heart failure accompanied by either:
✓. On optimal, maximally tolerated Guideline Directed Medical Therapy (GDMT) (medications and devices) per current country specific guidelines (e.g. US follows AHA/ACC guidelines, Germany follows DGK/ESC guidelines) for the treatment of heart failure, when appropriate, throughout screening/baseline evaluation and for at least 4 weeks prior to consent:
✓. Six-minute hall walk (6MHW) ≥ 100 m AND ≤ 450 m within 15 days after consent.
✓. If female and of childbearing potential, must have a negative pregnancy test within 15 days after consent.
✓. Be an appropriate candidate for the trial and the surgical procedure as determined by the investigator or designee and the surgeon.