NCT06989580

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study aims to collect clinical data with regard to the two main study objectives: \- Objective arrhythmia: Assess the incidence of arrhythmias and the contribution of the BIOMONITOR to arrhythmia diagnosis and subsequent treatment. \- Objective heart failure events: Collect data from BIOMONITOR sensors and relate them to the heart failure status for development of a predictive algorithm for worsening HF.

Conditions

• Heart Failure
• Arrhythmia
• Decompensated Heart Failure
• Atrial Fibrillation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-22
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-05-25
• Last updated: 2025-09-08

Locations

2 sites across 2 countries: Belgium, Germany