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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard remote monitoring | Active Comparator | Standard remote monitoring of ICD or CRT-D and standard remote monitoring of heart failure |
|
| Remote monitoring with SmartSignalHF | Experimental | Remote monitoring with the SmartSignalHF device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmartSignalHF | Device | SmartSignalHF; a solution aiming to predict episodes of cardiac decompensation in patients implanted with an ICD or CRT-D |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite measure of all-cause mortality and HF hospitalizations | From enrollment to the end of follow-up at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Implicity | Recruiting | Paris | 75002 | France |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| HF RM standard of care | Device | HF RM standard of care defined in the country (France or Germany) |
|
| 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 | 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). | At baseline and at 12 months |
| 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 |