\[Plain language\]: 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.
Patient has diagnosed heart failure for ≥90 days and current symptoms compatible with NYHA class II-III (according to most recent assessment)
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
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
Single group
BIOMONITOR IV with study software
DeviceParticipants are inserted with a BIOMONITOR IV which is then turned into the investigational device by replacing the firmware with the study software.
Heart failure events confirmed by WHF Adjudication Committee
* Heart failure hospitalization * Worsening heart failure event without hospitalization
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
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