A new clinical trial is set to explore innovative approaches to managing heart failure among patients with cardiac implantable electronic devices (CIEDs). As of November 26, 2025, the study, sponsored by Implicity, is not yet recruiting participants. This initiative seeks to evaluate the effectiveness of the SmartSignalHF device and a standard remote heart failure care method.
In this article:
What changed?
The clinical trial, listed under ClinicalTrials.gov (NCT07247032), examines SmartSignalHF, a device designed to support decision-making through remote monitoring of patients with heart failure. Patients enrolled in the study will either be monitored using SmartSignalHF or receive standard care under pre-existing remote monitoring protocols for heart failure (HF RM).
This comes at a pivotal time as healthcare systems increasingly adopt digital health tools to enhance chronic disease care and alleviate strain on clinical resources. This initiative aligns with global trends toward the expansion of connected medical devices and personalized interventions.
Study details
The trial is focused on patients with various heart failure classifications, including Heart Failure with Reduced Ejection Fraction (HFrEF) and those using cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillators (ICDs). Specific inclusion demographics will address New York Heart Association (NYHA) Class II and III heart failure patients, along with individuals experiencing decompensated heart failure events.
The interventions will involve:
- SmartSignalHF: A connected digital tool tailored for real-world HF management.
- Standard remote monitoring care: Current practices involving remote observation and clinical decision-making.
The study intends to assess not only the technical performance and safety of these approaches but also their scalability and potential improvements in clinical outcomes.
Who is affected?
Targeted participants include patients with cardiac implantable electronic devices (CIEDs) already under remote observation. Clinical practitioners specializing in cardiology and heart failure management may find the study relevant when considering integration of advanced tools into care pathways.
Moreover, regulatory professionals, device manufacturers, and health technology stakeholders will want to follow developments closely, as results from this study may influence future guidelines for managing chronic heart conditions.
FAQ
- What is the SmartSignalHF device?
It is a connected digital platform that enables real-time remote monitoring and clinical decision support for heart failure management. - Who is sponsoring the study?
The sponsor is Implicity, an organization specializing in digital health solutions for cardiac care. - When does the study begin?
The trial is in a not-yet-recruiting phase as of November 2025, with future updates expected.
Conclusion
The prospective study led by Implicity aims to advance heart failure management for patients with CIEDs by comparing SmartSignalHF and standard remote care methods. Clinicians, regulatory bodies, and stakeholders are encouraged to monitor the trial’s outcomes, which could reshape chronic care delivery models.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or medical advice. Readers should consult appropriate professional resources for specific guidance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07247032?term=medical+device