Heart Failure Management for Patient With CIED Remotely Monitored

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.

Eligibility

Inclusion Criteria:

* 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)
* Non-activation of others HF multisensor algorithms
* Patient remote monitored on Implicity CIED platform
* Patient with a documented diagnosis of heart failure, eligible to reimbursement in France or Germany for HF remote monitoring
* Patient is willing to be remotely monitored for heart failure
* HF treated according to European Society of Cardiology (ESC) guidelines

Exclusion Criteria:

* 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
* Patients already receiving remote monitoring for heart failure
* Pregnant or breastfeeding women
* Subjects under legal protection

Conditions7

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