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

NCT06989580 | Recruiting

• 1 other identifier: HS068
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 2

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.

Conditions

Heart Failure; Arrhythmia; Decompensated Heart Failure; Atrial Fibrillation

Keywords

Worsening Heart Failure (WHF)

Outcome Measures

Primary Outcomes (2)

• Heart failure events confirmed by WHF Adjudication Committee

  * Heart failure hospitalization * Worsening heart failure event without hospitalization

  Whole study conduct (approx. 3.5 years)

• 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

  Whole study conduct (approx. 3.5 years)

Study Arms (1)

Single arm

OTHER

All study participants receive the investigational device

Device: BIOMONITOR IV with study software

Interventions

BIOMONITOR IV with study software DEVICE

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

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (2)

Ziekenhuis Oost Limburg AV

Genk, Belgium

RECRUITING

Peter Osypka Herzzentrum

Munich, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Failure; Arrhythmias, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thorsten Lewalter, Prof. Dr.

  Biotronik SE & Co. KG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Boergermann, PhD

CONTACT

+49 (0) 30 68905 1182; Jan.Boergermann@biotronik.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Only commercial features of the BIOMONITOR IV are open label. The additional sensor data recorded by the study software are blinded to investigators and participants.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Data collection

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 25, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: To be specified
• Access Criteria: See above

Locations

DE (1); BE (1)