Prospective Real World Heart Failure Management for Patient With CIED Remotely Monitored

Official Summary

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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 1,132 participants

Interventions

• DEVICE: SmartSignalHF — SmartSignalHF; a solution aiming to predict episodes of cardiac decompensation in patients implanted with an ICD or CRT-D
• DEVICE: HF RM standard of care — HF RM standard of care defined in the country (France or Germany)

Primary Outcomes

• Composite measure of all-cause mortality and HF hospitalizations (From enrollment to the end of follow-up at 12 months)

Secondary Outcomes

• All-cause mortality (From enrollment to the end of follow-up at 12 months)
• HF mortality (From enrollment to the end of follow-up at 12 months)
• HF hospitalizations (From enrollment to the end of follow-up at 12 months)
• HF readmissions (From enrollment to the end of follow-up at 12 months)
• HF outpatient visits (From enrollment to the end of follow-up at 12 months)

Trial Locations

• Implicity, Paris, France

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