Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCVRx, Inc.
About this trial
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
Qualifiers
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
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
Disqualifiers
Any contraindications to Barostim as noted in Instructions for Use.
An existing device which contraindicates Barostim specifically or unipolar therapy in general.
AHA/ACC Stage D heart failure.
Two or more NT-proBNP results >5,000 pg/mL or BNP >1,250 pg/mL in a stable outpatient setting within 3 months prior to consent. If participant is taking sacubitril/valsartan (i.e. Entresto®), NT-proBNP must be used for screening eligibility.
Trial design
Treatments tested in this trial
- Barostim System
- Usual care medical management
Treatment groups
2,500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov