Collecting Clinical Data to Improve Arrhythmia and Heart Failure Care Using BIOMONITOR IV Device with Specialized Software

What this Trial Is About

Researchers are studying patients with heart failure HF who often experience irregular heartbeats called arrhythmias, including a common type called atrial fibrillation AF. These arrhythmias can worsen heart failure, increasing the risk of strokes and death. While most knowledge comes from patients with devices like ICDs or CRTs, this study focuses on those who do not qualify for these devices. The goal is to better understand arrhythmias and worsening heart failure WHF in this group to help improve care. Participants receive a BIOMONITOR IV device, which is implanted and updated with special study software to collect detailed heart activity data remotely over a long period. The device also tracks fluid levels, breathing rate, and body position to provide more information that may predict WHF events. All participants use this investigational device throughout the study. During approximately 3.5 years of follow-up, researchers will monitor heart failure events confirmed by a committee and track arrhythmias and related treatments. Participants will attend follow-up visits in person and by phone, use a CardioMessenger device, and accept remote monitoring. The collected data will help develop a predictive algorithm for early intervention to reduce hospital visits and deaths related to worsening heart failure.

BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software