BATwire Kit de Implantes Estudo

Resumo breve

The purpose of this clinical investigation is to develop valid scientific evidence for the safety and effectiveness of the Barostim System delivered by the BATwire Implant Kit (BATwire Kit) in subjects with heart failure. Subjects may be enrolled if they meet the FDA approved PMA indication for use for the Barostim NEO or Barostim NEO2 device: Subjects who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP \< 1600 pg/ml and excludes patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.