CRT and/or ICD, Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure With Decompensation, Heart Failure With Reduced Ejection Fraction (HFrEF)
Conditions
Brief 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.
Detailed description
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).
Interventions
DEVICESmartSignalHF
SmartSignalHF; a solution aiming to predict episodes of cardiac decompensation in patients implanted with an ICD or CRT-D
DEVICEHF RM standard of care
HF RM standard of care defined in the country (France or Germany)
Sponsors
Implicity
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite measure of all-cause mortality and HF hospitalizations | From enrollment to the end of follow-up at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | From enrollment to the end of follow-up at 12 months | — |
| HF mortality | From enrollment to the end of follow-up at 12 months | — |
| HF hospitalizations | From enrollment to the end of follow-up at 12 months | — |
| HF readmissions | From enrollment to the end of follow-up at 12 months | — |
| HF outpatient visits | From enrollment to the end of follow-up at 12 months | — |
| All cause hospitalizations | From enrollment to the end of follow-up at 12 months | — |
| HF hospitalization duration | From enrollment to the end of follow-up at 12 months | — |
| Proportion of patients without contraindications receiving 4- drug GDMT | At 12 months | — |
| Proportion of patients achieving ≥ 50% target doses or maximum tolerated doses for each drug class | At 12 months | — |
| Proportion of patients achieving 100% target doses or maximum tolerated doses for each drug class | At 12 months | — |
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score | At baseline and at 12 months | 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). |
| Rate of patients who completed the study follow-up | At 12 months | — |
| Rate of premature study discontinuation due to withdrawal of consent for remote monitoring | From enrollment to the end of follow-up at 12 months | — |
| Data completion rate | At 12 months | — |
| Adverse events linked to the device during the follow-up | From enrollment to the end of follow-up at 12 months | — |
Countries
France
Outcome results
None listed