Study of SmartSignalHF Device Versus Standard Remote Monitoring for Adults With Heart Failure and Implanted Cardiac Devices

What this Trial Is About

Researchers are evaluating the effectiveness of SmartSignalHF, a new digital health tool, compared with standard remote monitoring for patients with heart failure who have implanted Cardiac Implantable Electronic Devices CIEDs like ICD or CRT-D. This study aims to see whether SmartSignalHF can reduce deaths from any cause and hospital visits due to heart failure over 12 months. The trial involves adults diagnosed with New York Heart Association NYHA class II or III heart failure and reduced heart function. Participants will be randomly assigned to one of two groups one receiving standard remote monitoring of their implanted devices and heart failure condition, and the other using the SmartSignalHF system. SmartSignalHF continuously analyzes device and patient data to provide timely alerts to healthcare teams, potentially allowing earlier detection of heart failure worsening and better treatment adjustments. Both groups will be followed for 12 months after starting the study. During the study, participants will be monitored remotely, with data collected on all-cause mortality, heart failure hospitalizations, quality of life, and adherence to recommended medications. Researchers will track various health outcomes through questionnaires and medical records over the full year. Safety and data completeness will also be assessed, with the goal of understanding how well SmartSignalHF supports heart failure management in real-world settings.

Heart Failure Management for Patient With CIED Remotely Monitored