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Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction (ANTHEM-HFrEF)
To assess the safety and efficacy of the VITARIA System when added to stable, guideline directed medical therapy for patients with heart failure and reduced left ventricular ejection fraction.
18 year(s) or older
Inclusion Criteria:Have an Ejection Fraction (EF) ≤ 35%
Exclusion Criteria:Chronic (permanent) atrial fibrillation, or previous ablation for atrial fibrillation
Pregnant, planning on getting pregnant, or breastfeeding during the study
Previous or current implanted system or lead for vagus or other nerve stimulation
Heart failure due to congenital heart disease, hypertrophic obstructive cardiomyopathy, or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
Heart & Vascular