NCT07247032Recruiting
Heart Failure Management for Patient With CIED Remotely Monitored
Prospective Real World Heart Failure Management for Patient With CIED Remotely Monitored
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1132 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 19 Dec 2025
- Primary completion date
- May 2027
- Lead sponsor
- Implicity
- Diseases
- Heart failure
- NCT number
- NCT07247032
What you commit to
- Study type: Interventional
- Planned participants: 1132
- From 19 Dec 2025 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients enrolled in concurrent clinical studies
- Patients already receiving remote monitoring for heart failure
Other illness
- Patients undergoing or awaiting heart transplant or left ventricular assist device (LVAD) procedures
- Patients with a history of non-compliance with medical care or inability to comply with the study protocol
Other
- Patients with a life expectancy of less than 12 months
- Pregnant or breastfeeding women
- Subjects under legal protection
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Implicity Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.