RecruitingNot ApplicableNCT06989580

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

Sponsor

Biotronik SE & Co. KG

Enrollment

300 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure Atrial Fibrillation Arrhythmia Decompensated Heart Failure

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. 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria11

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 Criteria10

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

Interventions

DEVICEBIOMONITOR IV with study software

Participants are inserted with a BIOMONITOR IV which is then turned into the investigational device by replacing the firmware with the study software.