This randomized, controlled, open-label, parallel, multicenter clinical study evaluates the efficacy of SmartSignalHF compared with heart failure (HF) remote monitoring (RM) standard of care in implanted patients with heart failure. The primary objective is to determine whether SmartSignalHF reduces all-cause mortality and HF hospitalizations at 12 months.
Patient aged 18-85
Patient diagnosed with a New York Heart Association (NYHA) class II or III
Patients with left ventricular ejection fraction ≼ 40 %
Patient implanted with an ICD or CRT-D (BiV and/or LBBA pacing) since at least 30 days and compatible with SignalHF (Biotronik, Boston Scientific and Medtronic)
Patients undergoing or awaiting heart transplant or left ventricular assist device (LVAD) procedures
Patients with a life expectancy of less than 12 months
Patients enrolled in concurrent clinical studies
Patients with a history of non-compliance with medical care or inability to comply with the study protocol
Implicity
Lead sponsor