BIOMONITOR III Pooled Analysis
New Generation Miniaturized Insertable Cardiac Monitor with a Long Sensing Vector: Insertion Procedure, Sensing Performance, and Home Monitoring Transmission Success in a Real-World Population
Deneke T et al., Heart Rhythm O2, 2022
Study Design
- Pooled analysis including patients from the BIO|MASTER.BIOMONITOR III study or BIO|STREAM.ICM registry
- To evaluate the BIOMONITOR III ICM regarding simplicity of the insertion procedure, low complication rate, long-term patient acceptance, sensing quality, and reliable remote monitoring
- 653 patients inserted with a BIOMONITOR III device
Key Result 1
- 1 minute median insertion time until removal of the insertion tool
- 0.73 mV mean R-wave amplitude
- >99% noise-free sensing
- 95.1% visible P-waves in all heart cycles in Sinus Rhythm ECGs
- ≈94% Home Monitoring transmission success rate
- 0.9% serious adverse device-related events; 0 pocket infection requiring invasive intervention
- 97.1% excellent or good wearing comfort perceived by patients
Clinical Relevance
- The miniaturized implantable cardiac monitor (ICM) BIOMONITOR III has a uniquely long sensing vector, a fast insertion tool for pocket formation and ICM placement in one step, and daily automatic Home Monitoring (HM) function
- ICMs require an invasive procedure and are used for purely diagnostic purposes, therefore, simplicity of the insertion procedure, low complication rate, long-term patient acceptance, sensing quality, and reliable remote monitoring are of great importance
- The study demonstrated fast insertion times, low complication rate, high patient acceptance, and favorable long-term sensing and HM performance of the BIOMONITOR III
Study Objective |
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Primary Endpoint |
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Clinical Sites |
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Sample Size |
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Main Inclusion Criteria |
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Follow-Up |
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Reference no. |
NCT04025710 (BIO|MASTER.BIOMONITOR III) |
Principal Investigators |
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