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

Not Applicable

Recruiting

• Conditions: Heart Failure; Decompensated Heart Failure; Arrhythmia; Atrial Fibrillation

• Registration Number: NCT06989580
• Lead Sponsor: Biotronik SE & Co. KG

Brief 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.

Detailed Description

This study aims to collect clinical data with regard to the two main study objectives:

\- Objective arrhythmia: Assess the incidence of arrhythmias and the contribution of the BIOMONITOR to arrhythmia diagnosis and subsequent treatment.

\- Objective heart failure events: Collect data from BIOMONITOR sensors and relate them to the heart failure status for development of a predictive algorithm for worsening HF.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-05-23
• Study First Posted: 2025-05-25
• Study Start: 2025-08-22
• Last Update Submitted: 2025-09-05
• Last Update Posted: 2025-09-08
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Heart failure events confirmed by WHF Adjudication Committee	Whole study conduct (approx. 3.5 years)	* Heart failure hospitalization; * Worsening heart failure event without hospitalization
Arrhythmias and subsequent therapeutic interventions	Whole study conduct (approx. 3.5 years)	* 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

Trial Locations

Locations (2)

Ziekenhuis Oost Limburg AV; 🇧🇪 Genk, Belgium

Peter Osypka Herzzentrum; 🇩🇪 Munich, Germany