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BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software
Sponsor: Biotronik SE & Co. KG
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.
Official title: Clinical Data Collection to Develop Improved Arrhythmia and Heart Failure Management Using BIOMONITOR
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-08-22
Completion Date
2028-12-31
Last Updated
2025-09-08
Healthy Volunteers
No
Interventions
BIOMONITOR IV with study software
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)
Ziekenhuis Oost Limburg AV
Genk, Belgium
Peter Osypka Herzzentrum
Munich, Germany