Heart FailureNCT06989580
BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software
A study testing BIOMONITOR IV with study software in people with Heart Failure and Arrhythmia, run by Biotronik SE & Co. KG at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Arrhythmia, Decompensated Heart Failure
- What is being tested?
- BIOMONITOR IV with study software
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Aug 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
- Stroke, MI or PCI/CABG within 3 months prior to enrollment
- Patient is on chronic renal or peritoneal dialysis
- Patient has complex adult congenital heart disease
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- Patient has active cancer involving chemotherapy, immunotherapy or radiation therapy
- Patient life expectancy is less than 1 year
- Age <18 years
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost Limburg AV
Genk
Matthias Dupont, MD
Germany1 site, 1 recruiting
- Not yet recruiting
Peter Osypka Herzzentrum
Munich
Thorsten Lewalter, MD
About this study
Official title: 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.
Read the detailed description
This study aims to collect clinical data with regard to the two main study objectives:
- Objective arrhythmia: Assess the incidence of arrhythmias and the contribution of the BIOMONITOR to arrhythmia diagnosis and subsequent treatment.
- Objective heart failure events: Collect data from BIOMONITOR sensors and relate them to the heart failure status for development of a predictive algorithm for worsening HF.
- Being tested
- BIOMONITOR IV with study software
- Keywords
- Worsening Heart Failure (WHF)
- Medical subject headings
- Heart Failure, Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOMONITOR IV with study softwareDevice
Participants are inserted with a BIOMONITOR IV which is then turned into the investigational device by replacing the firmware with the study software.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | All study participants receive the investigational device Receives: Device: BIOMONITOR IV with study software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure events confirmed by WHF Adjudication Committee
- Heart failure hospitalization
- Worsening heart failure event without hospitalization
Measured: Whole study conduct (approx. 3.5 years)
Arrhythmias and subsequent therapeutic interventions
- Incidence of new diagnoses of arrhythmias, by type and therapeutic consequences
- Percentage of patients for which the BIOMONITOR contributed to newly diagnosed arrhythmias
- Percentage of patients for which the BIOMONITOR contributed to the decision to initiate an arrhythmia therapy
Measured: Whole study conduct (approx. 3.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start22 Aug 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Data collection
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thorsten Lewalter, Prof. Dr., Principal investigator, Biotronik SE & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989580
- Sponsor's protocol ID
- HS068
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data may be shared with qualified healthcare practitioners or academic researchers upon request and with permission of BIOTRONIK. Requests shall be sent to the Clinical Research Department of BIOTRONIK.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Data Collection to Develop Improved Arrhythmia and Heart Failure Management Using BIOMONITOR
- ClinicalTrials.gov ID
- NCT06989580
- Acronym / sponsor ID
- HS068
- Keywords
- Worsening Heart Failure (WHF)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
[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.
Detailed description
This study aims to collect clinical data with regard to the two main study objectives:
- Objective arrhythmia: Assess the incidence of arrhythmias and the contribution of the BIOMONITOR to arrhythmia diagnosis and subsequent treatment.
- Objective heart failure events: Collect data from BIOMONITOR sensors and relate them to the heart failure status for development of a predictive algorithm for worsening HF.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Data collection
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Device: BIOMONITOR IV with study softwareAll study participants receive the investigational device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
- If LVEF >50% --> Patients in SR: >450 / >150 pg/ml; Patients with AF present: >900 / >300 pg/ml
Key exclusion criteria (10 listed)
- 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
- Stroke, MI or PCI/CABG within 3 months prior to enrollment
- Patient is on chronic renal or peritoneal dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOMONITOR IV with study softwareParticipants are inserted with a BIOMONITOR IV which is then turned into the investigational device by replacing the firmware with the study software. | Device | Single arm |
Primary outcome
Heart failure events confirmed by WHF Adjudication Committee
Time frame: Whole study conduct (approx. 3.5 years)
* Heart failure hospitalization * Worsening heart failure event without hospitalization
Arrhythmias and subsequent therapeutic interventions
Time frame: Whole study conduct (approx. 3.5 years)
* Incidence of new diagnoses of arrhythmias, by type and therapeutic consequences * Percentage of patients for which the BIOMONITOR contributed to newly diagnosed arrhythmias * Percentage of patients for which the BIOMONITOR contributed to the decision to initiate an arrhythmia therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Yes. Anonymized data may be shared with qualified healthcare practitioners or academic researchers upon request and with permission of BIOTRONIK. Requests shall be sent to the Clinical Research Department of BIOTRONIK.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thorsten Lewalter, Prof. Dr. principal investigator
Biotronik SE & Co. KG
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIOMONITOR IV with study software in people with Heart Failure and Arrhythmia, run by Biotronik SE & Co. KG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Boergermann, PhD (+49 (0) 30 68905 1182, Jan.Boergermann@biotronik.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart failure events confirmed by WHF Adjudication Committee (time frame: Whole study conduct (approx. 3.5 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.