Heart Failure Management for Patient With CIED Remotely Monitored

Recruiting now · Not applicable

Conditions studied: Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure With Decompensation, CRT and/or ICD

In brief

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.

Key facts

Study ID

NCT07247032

Run by

Implicity

People needed

1132

Starts

2025-12-19

Expected to finish

2027-05-01

Last updated by the study team

2026-03-31

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Implicity — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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