Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
Trial Parameters
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Brief 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).
Eligibility Criteria
Inclusion Criteria: 1. Age 18 years or above 2. NYHA Functional Class II or III heart failure symptoms at the time of screening 3. Left ventricular ejection fraction \< 50% within 6 months of consent 4. Heart failure accompanied by either: * Screening local lab NT-proBNP ≥ 400 AND \< 5,000 pg/mL or a BNP ≥100 AND \< 1,250 pg/mL, adjusted for BMI in a stable outpatient setting OR * A documented Worsening Heart Failure Event in the 6 months prior to or concurrent with consent, AND an NT-proBNP \< 5,000 pg/mL or BNP \< 1,250 pg/mL, adjusted for BMI in a stable outpatient setting. Note: If participant is taking sacubitril/valsartan (i.e. Entresto®), NT-proBNP must be used for screening eligibility. NT-proBNP and BNP to be adjusted for BMI using a 4% reduction per BMI unit over 25 kg/m2. 5. 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 gu