Tests a heart monitor device in people with heart failure and irregular heartbeats
Tests a remote heart monitor to track rhythm problems in adults with heart failure.
Plain-language title generated from the registry record
Registry title: BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software
Key facts
- Where
- Genk, BelgiumSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with heart failure (NYHA class II-III) who do not have a pacemaker, ICD or CRT device. A heart monitor called BIOMONITOR IV collects data.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Heart failure diagnosed for at least 90 days, with symptoms of NYHA class II-III. Also at least one of: a hospital stay for worsening heart failure in the last 12 months, an unplanned visit for more or IV diuretics or ultrafiltration in the last 6 months, or raised NT-proBNP/BNP values in the last 3 months.
- Earlier treatment
- People with a pacemaker, ICD, CRT device or implanted heart monitor (ICM) cannot join.
- Biomarker or test result
- Raised NT-proBNP/BNP values within the last 3 months are one way in. The cut-off depends on LVEF (above or below 50%) and on heart rhythm (sinus rhythm or atrial fibrillation).
Main reasons for not taking part
- Pacemaker, ICD, CRT device or ICM already implanted
- Class I indication for a pacemaker, ICD or CRT
- Permanent or long-standing persistent atrial fibrillation
- Stroke, heart attack, PCI or CABG within 3 months before enrolment
- Dialysis, complex adult congenital heart disease, active cancer treatment, or life expectancy under 1 year
Read by machine on 12 November 2026.
Where in Belgium
- Ziekenhuis Oost Limburg AVGenk, BelgiumContact: Matthias Dupont, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Biotronik SE & Co. KG
- Trial code
- NCT06989580
- Record updated
- 8 September 2025
- Original description
[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.Read full original descriptionShow less
Clinical Data Collection to Develop Improved Arrhythmia and Heart Failure Management Using BIOMONITOR
[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.
Inclusion: Patient has diagnosed heart failure for ≥90 days and current symptoms compatible with NYHA class II-III (according to most recent assessment); At least ONE of the following:; At least one documented admission with a primary diagnosis of worsening heart failure within last 12 months prior to enrollment; OR Unscheduled outpatient visit with increase of oral loop diuretics (more than 2-fold) or IV diuretic or ultrafiltration therapy for acute WHF within last 6 months prior to enrollment; OR elevated NT-proBNP/BNP values within last 3 months prior to enrollment i.e.:; If LVEF >50% --> Patients in SR: >450 / >150 pg/ml; Patients with AF present: >900 / >300 pg/ml; If LVEF <50% --> Patients in SR: >900 / >300 pg/ml; Patients with AF present: >1800 / >450 pg/ml; Ability to understand the nature of the study; Willingness to provide written informed consent; Ability and willingness to perform follow-up visits at the study site and via phone; Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept.
Exclusion: Stroke, MI or PCI/CABG within 3 months prior to enrollment; Patient is participating in any other device or drug trial that may interfere with the treatment or protocol of this study or may significantly affect the study outcomes; Patient has complex adult congenital heart disease; Patient has active cancer involving chemotherapy, immunotherapy or radiation therapy; Age <18 years; Implanted with pacemaker, ICD or CRT device or ICM; Class I indication for a pacemaker, ICD or CRT according to current guidelines; Permanent or long-standing persistent AF; Patient is on chronic renal or peritoneal dialysis; Patient life expectancy is less than 1 year.