BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software

Launched by BIOTRONIK SE & CO. KG · May 23, 2025

Keywords

ClinConnect Summary

The BIO|CONCEPT.BIOMONITOR-HF trial is studying patients with heart failure who experience irregular heartbeats, known as arrhythmias. A common type of arrhythmia in these patients is atrial fibrillation, which can worsen their condition and increase the risk of serious events like strokes. This study focuses on heart failure patients who do not have devices like pacemakers or ICDs to monitor their heart rhythms. Researchers will use a new device called the BIOMONITOR IV to track heart activity over time and collect additional information, such as fluid levels and breathing rates. The goal is to better understand how often these arrhythmias happen and to create a tool that can predict when a patient’s heart failure might worsen, allowing for earlier medical intervention.

To participate, patients must have been diagnosed with heart failure for at least 90 days and have certain symptoms. They should also have a history of worsening heart failure or specific heart-related test results in the past year. Participants will need to be willing to attend follow-up visits and use the monitoring device. However, those with certain conditions, such as having a pacemaker or cancer treatment, will not be eligible. This trial aims to improve heart failure management and potentially reduce hospital visits and serious health issues related to worsening heart failure.

Gender

ALL

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