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RECRUITING
NCT06989580
NA

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

View on ClinicalTrials.gov

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

DEVICE

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