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CLP-AF-004_Visualise Etiology of Recurrent AF after failed AF ablation

  • Research type

    Research Study

  • Full title

    Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Recurrent Atrial Fibrillation Following a Failed AF Ablation

  • IRAS ID

    239296

  • Contact name

    Stephen Murray

  • Contact email

    stephen.murray6@nhs.net

  • Sponsor organisation

    Acutus Medical

  • Clinicaltrials.gov Identifier

    NCT02825992

  • Duration of Study in the UK

    2 years, 2 months, 1 days

  • Research summary

    Treatment for an irregular heart beat can be with medicines, electrical shocks or re-ablation therapy. Atrial fibrillation (AF) is caused by rapid impluses of electricity that comes from the upper chambers of the heart (left or right atrium). This new device allows the doctor to "map" the exact places the impulses are coming from in order to better target the best places for ablation.

    AF is among the most prevalent arrhythmias in the world today affecting approximately 1.5-2% of the general population. The age of patients with AF is steadily rising and now averages between 75 and 85 years of age. AF is associated with five-fold risk of stroke, a three-fold incidence of congestive hear failure and higher mortality.

    The AcQMap High Resolution Imaging and Mapping System (AcQMap System) has been designed to provide information on cardiac dipole densities as a function of time and project that information on an image of a cardiac chamber. In this study, the AcQMap System will collect data from the AcQMap 3D Imaging and Mapping Catheter (AcQMap Catheter) to create anatomical reconstructions of the chamber(s) being mapped and to create dipole density maps on those reconstructions. These maps will then be used to identify mechanisms of AF, which can be targeted for ablation.

    Eligible patients for this study must be over the age of 18 and have had no more than 2 previous left-atrial ablations for AF treatment in the past 24 months.

    This study will take place in up to 15 sites in Europe and approximately 100 patients will participate.

    The study will last for approximately 12 months and will have to visit the hospital 5 times during this period.

  • REC name

    North East - Newcastle & North Tyneside 2 Research Ethics Committee

  • REC reference

    18/NE/0033

  • Date of REC Opinion

    14 Feb 2018

  • REC opinion

    Favourable Opinion