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

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

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.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Biotronik SE & Co. KG (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 2 sites (Genk and 1 other locations)
• Trial ID: NCT06989580 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Genk and 1 other locations

• Ziekenhuis Oost Limburg AV — Genk, Belgium (Recruiting)
• Peter Osypka Herzzentrum — Munich, Germany (Not_yet_recruiting)

Study contacts

• Principal investigator: Thorsten Lewalter, Prof. Dr. — Biotronik SE & Co. KG
• Study coordinator: Jan Boergermann, PhD

Conditions Heart Failure; Arrhythmia; Decompensated Heart Failure; Atrial Fibrillation; Worsening Heart Failure