Actively Recruiting
Heart Failure Management for Patient With CIED Remotely Monitored
Led by Implicity · Updated on 2026-03-31
1132
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Heart Failure Management for Patient With CIED Remotely Monitored
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18-85
- Diagnosed with New York Heart Association (NYHA) class II or III heart failure
- Left ventricular ejection fraction less than or equal to 40%
- Implanted with an ICD or CRT-D for at least 30 days and compatible with SmartSignalHF
- No activation of other heart failure multisensor algorithms
- Remotely monitored on the Implicity CIED platform
- Documented heart failure diagnosis eligible for reimbursement in France or Germany
- Willing to be remotely monitored for heart failure
- Heart failure treated according to European Society of Cardiology (ESC) guidelines
You will not qualify if you...
- Undergoing or awaiting heart transplant or left ventricular assist device (LVAD) procedures
- Life expectancy less than 12 months
- Enrolled in other clinical studies
- History of non-compliance with medical care or inability to follow study protocol
- Already receiving remote monitoring for heart failure
- Pregnant or breastfeeding
- Under legal protection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Implicity
Paris, France, 75002
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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