• Cardiac Rhythm Management (CRM)
    • Schrittmachersysteme
    • Implantierbare Cardioverter-Defibrillator (ICD) Systeme
    • Kardiale Resynchronisationstherapie (CRT)
    • Implantierbare Herzmonitoring-Systeme (ICM)
    • Systeme zur Fernüberwachung von Patienten
    • Programmiergeräte und externe Geräte
    • Einführungssysteme für Elektroden
  • Vaskuläre Intervention
    • Koronare vaskuläre Intervention
    • Periphere vaskuläre Intervention
  • Elektrophysiologie
    • Therapien
    • Diagnostik
    • Transseptal
    • Temporäre Stimulation
  • Strahlenschutz
    • Zero-Gravity

BioVAD Clinical Trial

Accuracy of atrial fibrillation detection by an insertable cardiac monitor in patients undergoing catheter ablation: Results of the BioVAD study

Assaf A et al., Ann Noninvasive Electrocardiol., 2022

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 Results

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

BIO VAD Key result 1

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 Details

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 above the age of 18 
  • scheduled to undergo catheter ablation of paroxysmal or persistent AF

Main Exclusion Criteria

  • Patients with long-standing persistent AF and permanent AF

Principal Investigators

  • Sing-Chien Yap, Erasmus MC, University Medical Center Rotterdam, The Netherlands

Related Link

Link to Publication

Results of the BioVAD study