Call us
+(374)77 435-777

BioVAD


BioVAD

Study Design

  • Prospective, observational, single-center study
  • To evaluate the AF detection performance of BIOMONITOR III in patients before and after AF ablation
  • 31 patients scheduled for catheter ablation of paroxysmal or persistent AF

 

Key Result 1

All true AF episodes were detected by the BIOMONITOR III

  • 100% episode-based sensitivity

The BIOMONITOR III identified all patients with AF

  • 100% patient-based sensitivity


BIOMONITOR III provided highly accurate AF burden estimation before and after catheter ablation

  • 99.6% duration-based accuracy before catheter ablation
  • 99.8% duration-based accuracy after catheter ablation

 

Key Result 2

78% reduction in false-positive episodes with RhythmCheck, the new ectopy rejection algorithm designed to minimize false positive AF detections due to ectopy


Clinical Relevance

  • Insertable cardiac monitors (ICMs) are increasingly used to evaluate the atrial fibrillation (AF) burden after catheter ablation of AF
  • Continuous monitoring provides the opportunity to establish the AF burden, which may have a better correlation with functional outcome than mere documentation of AF recurrence by intermittent rhythm monitoring strategies
  • BIOMONIROR III accurately detects AF burden in patients before and after catheter ablation of AF

 


Study Objective
  • To evaluate the AF detection performance of BIOMONITOR III in patients before and after AF ablation
Primary Endpoint
  • To determine the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the ICM in detecting AF compared to simultaneous Holter monitoring before and after catheter ablation

Clinical Sites
  • Single-center study, conducted in the Erasmus Medical Center (Rotterdam, the Netherlands)
Sample Size
  • 31 patients
Main Inclusion Criteria
  • Patients with severe reflex syncopies
  • ≥ 40 years of age
  • ≥ 2 episodes in the last year
  • Tilt table-induced syncope with asystolic pause > 3 seconds
  • Alternate therapies have failed or were not feasibile
  • Exclusion of other possible competitive causes of syncope

Main Exclusion Criteria
  • Scheduled to undergo catheter ablation of paroxysmal or persistent AF
Principal Investigators
  • Sing-Chien Yap, Erasmus MC, University Medical Center Rotterdam, The Netherlands

11/08/2022