BIOMONITOR 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.