RecruitingNot ApplicableNCT06989580

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


Sponsor

Biotronik SE & Co. KG

Enrollment

300 participants

Start Date

Aug 22, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world clinical data from heart failure patients who have had an implantable cardiac monitor (called BIOMONITOR) inserted, in order to better understand patterns in heart failure and improve remote monitoring and care. **You may be eligible if...** - You have had a heart failure diagnosis for at least 90 days and currently have moderate symptoms (NYHA class II–III) - You have had at least one of the following in the past 6–12 months: a hospitalization for worsening heart failure, an unscheduled visit requiring IV diuretics or ultrafiltration, or elevated heart failure biomarker levels (NT-proBNP or BNP) - You are planned to receive or already have a BIOMONITOR implantable cardiac monitor **You may NOT be eligible if...** - You do not meet the heart failure severity criteria - You have conditions that prevent safe use of the BIOMONITOR device Talk to your doctor to see if this trial is right for you.

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

DEVICEBIOMONITOR 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

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NCT06989580


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