NCT06989580Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
\[Plain language\]: 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 17 Apr 2025
- Start date
- 22 Aug 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Biotronik SE & Co. KG
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT06989580
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 22 Aug 2025 to the primary completion date, 31 Dec 2028
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patient has complex adult congenital heart disease
- Patient has active cancer involving chemotherapy, immunotherapy or radiation therapy
Age
- Age \<18 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ziekenhuis Oost Limburg AV Coordinator of this site? Confirm its status | Genk | Belgium | Recruiting |
| Peter Osypka Herzzentrum Coordinator of this site? Confirm its status | Munich | Germany | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.