Status:
RECRUITING
BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Heart Failure
Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
NA
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, leadin...
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 arrhythmi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06989580
Start Date
August 22 2025
End Date
December 31 2028
Last Update
September 8 2025
Active Locations (2)
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1
Ziekenhuis Oost Limburg AV
Genk, Belgium
2
Peter Osypka Herzzentrum
Munich, Germany