Clinical Research Directory

Inclusion Criteria: 1. Heart failure with a reduced LV ejection fraction (≤40%) and documented heart failure for at least 6 months from Baseline Visit. 2. NYHA Class III symptoms 3. Receiving guideline directed medical therapy (GDMT) for heart failure which refers to those HF drugs carrying a Class I indication: 1. An inhibitor of the renin-angiotensin system (RAS inhibitor), including an angiotensin receptor-neprilysin inhibitor (ARNI), angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and an evidence-based beta-blocker (BB) for at least 3 months prior to the Baseline Visit 2. An SGLT2I Inhibitor for at least 1 month prior to the Baseline Visit 3. Other medications recommended for selected populations, e.g., on diuretics as required for volume control. Mineralocorticoid receptor antagonist (MRA) or nitrates/hydralazine should be used in appropriate patients, according to the published guidelines. 4. All patients are on stable HF medications as determined by the investigator, for at least 1 month, with the exception of diuretic therapy. Stable is defined as no more than a 100% increase or 50% decrease in dose within these periods. 4. Receiving Class I recommended cardiac rhythm management device therapy. Specifically: if indicated by class I guidelines, cardiac resynchronization therapy (CRT), implanted cardioverter-defibrillator (ICD) or a pacemaker should be implanted at least 3 months prior to Baseline Visit. 5. Must meet 5a OR 5b. 1. One (1) prior Heart Failure Hospitalization with duration \>24 hours or Emergency Room Heart Failure Visit with duration ≥6 hours, or Heart Failure Clinic ADHF Visit with duration ≥6 hours, within 12 months from Baseline Visit. 2. Alternatively, if patients have not had a HF hospitalization or ER HF Visit within the prior 12 months, they must have a BMI corrected elevated Brain Natriuretic Peptide (BNP) level of at least 300 pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at least 1,500 pg/ml, according to local measurement, within 3 months of the Baseline Visit. 6. Able to perform the 6-minute walk test with a distance ≥100 meters and ≤450 meters. 7. Provide written informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits. Main Exclusion Criteria: * Resting systolic blood pressure \<90 or \>160 mmHg * Baseline echocardiographic evidence of intracardiac blood clot, significant right ventricular dysfunction or severe left sided dilation. * Diagnosis of severe pulmonary hypertension. * Congenital Atrial septal defect, patent foramen ovale, with known shunting on echo * Untreated moderately severe or severe aortic or mitral stenosis. * Mitral valve repair device (e.g. MitraClip) implanted within 3 months prior to Baseline Visit. * Acute MI, acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), rhythm management system revision (not including generator change), lead extraction, or cardiac or other major surgery within 3 months of Baseline Visit. * Stroke, transient ischemic attack (TIA), systemic or pulmonary thromboembolism, or deep vein thrombosis (DVT) within 6 months. * Intractable HF with any of the following: Treatment with IV vasoactive medications (e.g., IV inotropes, IV vasodilators) within the last 30 days. Treated with a ventricular assist device (VAD). Listed for cardiac transplantation. * Prior cardiac transplantation. * Life expectancy \<1 year due to non-cardiovascular illness. * Kidney failure or is receiving dialysis. * Active infection requiring parenteral or oral antibiotics. * Known allergy to nickel. * Hemodynamic, heart rhythm or respiratory instability at the time of Final Exclusion Criteria.