RecruitingRecruiting
BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software
NCT06989580 · Biotronik SE & Co. KG
In plain English
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Official title
Clinical Data Collection to Develop Improved Arrhythmia and Heart Failure Management Using BIOMONITOR
About this study
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.
Eligibility criteria
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
Enrollment target: 300 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-22
Estimated completion: 2028-12-31
Last updated: 2025-09-08
Interventions
Device: BIOMONITOR IV with study software
Primary outcomes
- • Heart failure events confirmed by WHF Adjudication Committee (Whole study conduct (approx. 3.5 years))
- • Arrhythmias and subsequent therapeutic interventions (Whole study conduct (approx. 3.5 years))
Sponsor
Biotronik SE & Co. KG · industry
Contacts & investigators
ContactJan Boergermann, PhD · contact · Jan.Boergermann@biotronik.com · +49 (0) 30 68905 1182
InvestigatorThorsten Lewalter, Prof. Dr. · principal_investigator, Biotronik SE & Co. KG
All locations (2)
Ziekenhuis Oost Limburg AVRecruiting
Genk, Belgium
Peter Osypka HerzzentrumNot Yet Recruiting
Munich, Germany