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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiotronik SE & Co. KG

About this trial

\[Plain language\]: 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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • BIOMONITOR IV with study software

Treatment groups

300 Participants
are divided into 1 treatment group

Sponsors and collaborators