Actively Recruiting
BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software
Led by Biotronik SE & Co. KG · Updated on 2025-09-08
300
Participants Needed
2
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
\[Plain language\]: 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.
CONDITIONS
Official Title
BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed heart failure for at least 90 days with current symptoms compatible with NYHA class II or III
- At least one of the following: hospital admission for worsening heart failure within last 12 months; or unscheduled outpatient visit with increased oral loop diuretics, IV diuretics, or ultrafiltration therapy for acute worsening heart failure within last 6 months; or elevated NT-proBNP/BNP values within last 3 months based on specified levels and heart function
- Ability to understand the study and provide written informed consent
- Willingness and ability to attend follow-up visits at the study site and via phone
- Ability and willingness to use the CardioMessenger device and accept the BIOTRONIK Home Monitoring system
You will not qualify if you...
- Implanted with pacemaker, ICD, CRT device, or insertable cardiac monitor
- Have a Class I indication for pacemaker, ICD, or CRT according to current guidelines
- Permanent or long-standing persistent atrial fibrillation
- Stroke, myocardial infarction, or PCI/CABG within 3 months prior to enrollment
- On chronic renal or peritoneal dialysis
- Complex adult congenital heart disease
- Active cancer receiving chemotherapy, immunotherapy, or radiation therapy
- Life expectancy less than 1 year
- Under 18 years of age
- Currently participating in another device or drug trial that may interfere with this study or affect outcomes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Ziekenhuis Oost Limburg AV
Genk, Belgium
Actively Recruiting
2
Peter Osypka Herzzentrum
Munich, Germany
Not Yet Recruiting
Research Team
J
Jan Boergermann, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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