N/A
N=467
Baroreflex Activation Therapy for Heart Failure
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02627196 ↗Enrolled (actual)
467
Serious AEs
74.9%
Results posted
Mar 2026
Primary outcome: Primary: Rate of Cardiovascular Mortality and Heart Failure Morbidity — .46; .48 Rate of Events Per Patient-Year — p=0.82
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BAROSTIM NEO® System (Device); Medical Management (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- CVRx, Inc.
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Cardiovascular Mortality and Heart Failure Morbidity |
.46; .48 | 0.82 |
| PRIMARY Major Adverse Neurological and Cardiovascular Events (MANCE) |
121 | 0.001 sig |
| PRIMARY Percent Change in Log 10 Amino-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) From Baseline to 6 Months Post-implant |
-21.1; 3.3 | .004 sig |
| PRIMARY Change to Six Minute Hall Walk (6MHW) |
48.6; -7.9 | <.001 sig |
| PRIMARY Change in Minnesota Living With Heart Failure Quality of Life (MLWHF QOL) Score |
-20.7; -6.2 | <.001 sig |
Summary
The purpose of this clinical trial (NCT02627196) is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy with the BAROSTIM NEO System in subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III, left ventricular ejection fraction (LVEF) ≤ 35% and NT-proBNP<1600 pg/ml despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT).
The total trial duration is anticipated to be approximately 5 years; however, the duration of an individual subject enrollment will depend on when he or she entered the trial.
Eligibility Criteria
Inclusion Criteria
- Age 21 years or above.
- Currently NYHA Class II or III heart failure. For NYHA Class II, must have been NYHA Class III at any point in time within 3 calendar months prior to enrollment or at time of screening (enrollment is defined as the date the subject provided written consent).
- Left ventricular ejection fraction ≤ 35% within 45 days prior to randomization.
- Heart failure accompanied by either:
- Core lab NT-proBNP ≥ 400 AND 40.
- Serum estimated glomerular filtration rate (eGFR) 100 bpm via clinic measurements within 45 days prior to randomization. (Note: Heart rate <60 bpm is not applicable to subjects with an implanted device capable of pacing.)
- Recurring symptomatic hypotension within 45 days prior to randomization.
- Significant uncontrolled symptomatic bradyarrhythmias or unstable ventricular arrhythmias.
- Subjects with any surgery that has occurred, or is planned to occur, within 45 days of the BAROSTIM NEO implant procedure. This includes pacemaker or ICD implants or battery replacements.
- Episode of NYHA class IV heart failure with acute pulmonary edema within 45 days prior to randomization.
- Any of the following within 3 months of randomization:
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention (e.g. CABG or PTCA)
- Cerebral vascular accident or transient ischemic attack
- Sudden cardiac death
- Solid organ or hematologic transplant, or currently being actively evaluated for an organ transplant.
- Has received or is receiving LVAD therapy.
- Has received or is receiving chronic dialysis.
- Heart failure secondary to a reversible cause, such as cardiac structural valvular disease, acute myocarditis and pericardial constriction.
- Primary pulmonary hypertension.
- Infiltrative cardiomyopathy (e.g. cardiac amyloidosis).
- Severe COPD or severe restrictive lung disease (e.g. requires chronic steroid use or home oxygen use).
- Active malignancy.
- Current or planned treatment with intravenous positive inotrope therapy.
- Life expectancy less than one year.
- Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
- Unable or unwilling to fulfill the protocol medication compliance, testing, and follow-up requirements (e.g. recent drug abuse).
- Enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical trial unless approved by the CVRx Clinical department.
- Subjects with known allergies to silicone and titanium.
Data sourced from ClinicalTrials.gov (NCT02627196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.