BIOMONITOR III Pooled Analysis Clinical Trial

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 Results

  • 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 Details

Study Objective

  • 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 

Primary Endpoint

  • No study hypotheses or statistical endpoints were predefined

Clinical Sites

  • 51 sites

Sample Size

  • 653 patients

Main Inclusion Criteria

  • Indication for ICM implantation in accordance with current clinical practice, including syncope or presyncope, detection of atrial fibrillation (AF) after cryptogenic stroke, AF burden monitoring, palpitations, and other conditions

Follow-Up

  • 274 days median follow-up

Study Duration

  • June 2015 - February 2020

Reference no.

  • NCT04025710 (BIO|MASTER.BIOMONITOR III)
  • NCT04075084 (BIO|STREAM.ICM)

Principal Investigators

  • Thomas Deneke, RHÖN-KLINIKUM Campus Bad Neustadt, Germany

Related Link

Link to Publication

New-generation miniaturized insertable cardiac monitor with a long sensing vector

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