Heart Failure Management for Patient With CIED Remotely Monitored (NCT07247032) | Clinical Trial Compass
RecruitingNot Applicable
Heart Failure Management for Patient With CIED Remotely Monitored
France1,132 participantsStarted 2025-12-19
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite measure of all-cause mortality and HF hospitalizations
Timeframe: From enrollment to the end of follow-up at 12 months