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

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.

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