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Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using BIOMONITOR IV to track heart rhythm and warning signs in people with heart failure

Official title: Clinical Data Collection to Develop Improved Arrhythmia and Heart Failure Management Using BIOMONITOR

Run by Biotronik SE & Co. KG · NCT06989580 · Data updated 2026-11-12

This project will test whether a small implanted monitor called BIOMONITOR IV can track irregular heartbeats and body signals in people with heart failure who do not have ICD/CRT devices to see if it can warn doctors before the heart failure gets worse.

More Heart Failure trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorBiotronik SE & Co. KG
Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations2 sites (Genk and 1 other locations)
StatusRecruiting
StartedAugust 22, 2025
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedSeptember 8, 2025
Trial IDNCT06989580 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with diagnosed heart failure for at least 90 days, current NYHA class II–III symptoms, and recent evidence of worsening heart failure (hospitalization, need for increased diuretics, or elevated NT-proBNP/BNP) who are willing to have BIOMONITOR IV implanted and attend follow-up visits.

Probably not a fit

Patients who already have ICD or CRT devices, those who cannot undergo device implantation, or those without recent signs of worsening heart failure are unlikely to benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with symptomatic heart failure (NYHA II–III) who meet recent worsening-heart-failure or biomarker criteria receive a BIOMONITOR IV device with updated firmware and study software for continuous remote sensing of cardiac rhythm, fluid status surrogates, breathing rate, and body position. Data are transmitted to the study team during routine follow-up visits and phone contacts, and arrhythmia incidence and device contribution to diagnosis and treatment are recorded. Sensor data will be correlated with clinical heart-failure events to develop and refine a predictive algorithm for worsening heart failure. The study focuses on patients who are not candidates for ICD or CRT devices and aims to improve early detection and management of WHF using long-term implantable monitoring.

Why it matters

Potential benefit: If successful, the device and algorithm could give earlier warnings of worsening heart failure and arrhythmias, enabling timelier treatment and potentially reducing hospital visits and deaths.

How similar studies have gone: Implantable monitors and device-based sensors have previously shown promise for detecting arrhythmias and physiologic changes in patients with ICD/CRT systems, but using a subcutaneous BIOMONITOR IV with a WHF predictive algorithm in non-device heart-failure patients is less well established.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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
* 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

Where it's running

  • Ziekenhuis Oost Limburg AV
    Genk, Belgium     Recruiting
  • Peter Osypka Herzzentrum
    Munich, Germany     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.