BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software
Clinical Data Collection to Develop Improved Arrhythmia and Heart Failure Management Using BIOMONITOR
Biotronik SE & Co. KG
300 participants
Aug 22, 2025
INTERVENTIONAL
Conditions
Summary
\[Plain language\]: Heart failure (HF) patients often experience irregular heartbeats, known as arrhythmias. Atrial fibrillation (AF) is common among HF patients and can worsen their condition, leading to strokes and higher death rates. Most of what we know about arrhythmias in HF comes from patients with devices like ICDs or CRTs, which help manage heart rhythms. However, this study focuses on HF patients who don't qualify for these devices. Researchers use the BIOMONITOR IV, a device that tracks heart activity remotely over a long period. The goal is to understand how often arrhythmias occur in these patients and to develop a predictive algorithm for worsening HF (WHF). This algorithm could help doctors intervene early and improve treatment, reducing hospital visits and deaths related to WHF. To make the BIOMONITOR IV more effective for HF management, its firmware is updated to collect additional data, such as fluid levels, breathing rate, and body position. These factors may be important for predicting WHF events.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Participants are inserted with a BIOMONITOR IV which is then turned into the investigational device by replacing the firmware with the study software.
Locations(2)
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NCT06989580