Actively Recruiting
Clinical Data Collection to Develop Improved Arrhythmia and Heart Failure Management Using BIOMONITOR
Led by Biotronik SE & Co. KG · Updated on 2025-09-08
300
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with heart failure (HF) who often experience irregular heartbeats called arrhythmias, including a common type called atrial fibrillation (AF). These arrhythmias can worsen heart failure, increasing the risk of strokes and death. While most knowledge comes from patients with devices like ICDs or CRTs, this study focuses on those who do not qualify for these devices. The goal is to better understand arrhythmias and worsening heart failure (WHF) in this group to help improve care. Participants receive a BIOMONITOR IV device, which is implanted and updated with special study software to collect detailed heart activity data remotely over a long period. The device also tracks fluid levels, breathing rate, and body position to provide more information that may predict WHF events. All participants use this investigational device throughout the study. During approximately 3.5 years of follow-up, researchers will monitor heart failure events confirmed by a committee and track arrhythmias and related treatments. Participants will attend follow-up visits in person and by phone, use a CardioMessenger device, and accept remote monitoring. The collected data will help develop a predictive algorithm for early intervention to reduce hospital visits and deaths related to worsening heart failure.
CONDITIONS
Brief 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...
- Patient has diagnosed heart failure for at least 90 days with current symptoms compatible with NYHA class II or III
- Has at least one of the following: a documented hospital admission for worsening heart failure within the last 12 months, or an unscheduled outpatient visit with increased diuretic therapy within the last 6 months, or elevated NT-proBNP/BNP values within the last 3 months
- Ability to understand the study and provide written informed consent
- Willingness to attend follow-up visits in person and by 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 implantable cardiac monitor
- Has a current Class I indication for pacemaker, ICD, or CRT
- Permanent or long-standing persistent atrial fibrillation
- Stroke, myocardial infarction, or heart surgery within 3 months prior to enrollment
- On chronic renal or peritoneal dialysis
- Has complex adult congenital heart disease
- Active cancer under chemotherapy, immunotherapy, or radiation
- Life expectancy less than 1 year
- Under 18 years of age
- Participating in another device or drug trial that may interfere with this study or affect outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants have a BIOMONITOR IV device inserted, which is then updated with study-specific research software to collect clinical data.
1 visit (in-person)
Duration - Approximately 3.5 years
Participants are monitored using the BIOMONITOR device and associated home monitoring system to collect data on arrhythmias and heart failure events over the study period.
Regular follow-up visits in person and by phone during the study period
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
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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