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Clinical Trials in France / NCT07247032
Recruiting Not applicable

Heart Failure Management for Patient With CIED Remotely Monitored

NCT07247032 · tracked via the Priya Life Science France tracker
Sponsor
Implicity
Phase
Not applicable
Started
2025-12-19
Last updated
2026-03-31

Condition(s) studied

Heart FailureHeart Failure NYHA Class IIHeart Failure NYHA Class IIIHeart Failure With Reduced Ejection Fraction (HFrEF)Heart Failure With DecompensationCRT and/or ICD

Investigational drug(s) / intervention(s)

SmartSignalHFHF RM standard of care

SmartSignalHF: SmartSignalHF; a solution aiming to predict episodes of cardiac decompensation in patients implanted with an ICD or CRT-D

HF RM standard of care: HF RM standard of care defined in the country (France or Germany)

Study 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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Implicity Paris France Recruiting

More Implicity trials in France

EValuation of prognostIc and Cost reDuction by tElemonitoring iN CIEDs Usual carE: an Updated Analysis Using 2019-2023 Data Active, not recruiting

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Personalized Therapy Study - Attain Stability Quad Post-Approval Study Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07247032 on ClinicalTrials.gov ↗ ← All trials in France