SmartSignalHF remote monitoring for people with implanted ICD or CRT‑D and heart failure
Official title: Prospective Real World Heart Failure Management for Patient With CIED Remotely Monitored
Run by Implicity · NCT07247032 · Data updated 2026-11-12
This tests whether SmartSignalHF remote monitoring for people with implanted ICD or CRT‑D and chronic heart failure can reduce deaths and heart failure hospital visits over 12 months compared with standard remote monitoring.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 1132 (estimated) |
| Sponsor | Implicity Industry-sponsored |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | December 19, 2025 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | March 31, 2026 |
| Trial ID | NCT07247032 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–85 with chronic NYHA class II–III heart failure and LVEF ≤40% who have had an ICD or CRT‑D compatible with SignalHF for at least 30 days and are enrolled on the Implicity remote monitoring platform in France or Germany.
✕Probably not a fit
Patients awaiting heart transplant or LVAD, those with life expectancy under 12 months, people not implanted with compatible devices, or those not on the Implicity platform are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, randomized, parallel, multicenter trial will enroll patients with chronic heart failure and an implanted ICD or CRT‑D compatible with the SignalHF platform and randomize them 1:1 to SmartSignalHF versus standard heart failure remote monitoring. SmartSignalHF continuously analyzes CIED and patient data to generate actionable alerts for care teams, while the control arm receives current standard remote monitoring. The primary endpoint is a composite of all-cause mortality and heart failure hospitalizations at 12 months, with secondary endpoints including quality of life and adherence to guideline-directed medical therapy. The trial focuses on patients already enrolled on the Implicity remote monitoring platform and uses remote data streams to prompt clinical interventions.
Why it matters
Potential benefit: If successful, SmartSignalHF could enable earlier detection of worsening heart failure, reduce hospital admissions and deaths, and help optimize guideline-directed treatments.
How similar studies have gone: Previous CIED-based remote monitoring studies have produced mixed results with some demonstrating reduced events (for example IN-TIME) while others did not, and SmartSignalHF's continuous analytics approach is relatively new and unproven in large randomized settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Implicity
Paris, France Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.