An interventional study of SmartSignalHF and HF RM standard of care in Heart Failure, Heart Failure NYHA Class II and Heart Failure NYHA Class III, sponsored by Implicity. Recruiting at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Implicity · Not applicable, Interventional, and Prevention
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.
SmartSignalHF is a novel digital health solution designed to support clinical decision-making by continuously analyzing Cardiac Implantable Electronic Devices (CIED) and patient data and providing actionable alerts to healthcare teams. By integrating this digital solution into the remote monitoring of HF patients, the study aims to enhance early detection of decompensation events and optimize therapeutic treatments.
Eligible patients implanted with an Implantable Cardioverter Defibrillator (ICD) or a Cardiac Resynchronization Therapy Defibrillator (CRT-D) and diagnosed with chronic heart failure will be randomized in a 1:1 ratio to either SmartSignalHF remote monitoring solution or standard HF remote monitoring solution.
The primary endpoint is a composite of all-cause mortality and HF hospitalizations within 12 months after randomization. Secondary endpoints include individual components of the primary endpoint, quality-of-life measures, and adherence to guideline-directed medical therapy (GDMT).
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 1,132 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Implicity as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard remote monitoring of ICD or CRT-D and standard remote monitoring of heart failure
Device: HF RM standard of care
Remote monitoring with the SmartSignalHF device
Device: 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 defined in the country (France or Germany)
Composite measure of all-cause mortality and HF hospitalizations
Time frame: From enrollment to the end of follow-up at 12 months
All-cause mortality
Time frame: From enrollment to the end of follow-up at 12 months
HF mortality
Time frame: From enrollment to the end of follow-up at 12 months
HF hospitalizations
Time frame: From enrollment to the end of follow-up at 12 months
HF readmissions
Time frame: From enrollment to the end of follow-up at 12 months
HF outpatient visits
Time frame: From enrollment to the end of follow-up at 12 months
All cause hospitalizations
Time frame: From enrollment to the end of follow-up at 12 months
HF hospitalization duration
Time frame: From enrollment to the end of follow-up at 12 months
Proportion of patients without contraindications receiving 4- drug GDMT
Time frame: At 12 months
Proportion of patients achieving ≥ 50% target doses or maximum tolerated doses for each drug class
Time frame: At 12 months
Proportion of patients achieving 100% target doses or maximum tolerated doses for each drug class
Time frame: At 12 months
Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score
The Minnesota Living With Heart Failure Questionnaire (MLHFQ) total score ranges from a minimum of 0 (best possible health-related quality of life) to a maximum of 105 (worst possible health-related quality of life).
Time frame: At baseline and at 12 months
Rate of patients who completed the study follow-up
Time frame: At 12 months
Rate of premature study discontinuation due to withdrawal of consent for remote monitoring
Time frame: From enrollment to the end of follow-up at 12 months
Data completion rate
Time frame: At 12 months
Adverse events linked to the device during the follow-up
Time frame: From enrollment to the end of follow-up at 12 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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