REWIRE-AF

  • Research type

    Research Study

  • Full title

    REassessment of posterior Wall isolation with IRreversible Electroporation - the REWIRE-AF trial: a Multicentre Prospective Randomised Study of Pulmonary Vein Isolation with and without Posterior Wall Isolation with Pulsed Field Ablation in Persistent Atrial Fibrillation

  • IRAS ID

    329725

  • Contact name

    Richard Balasubramaniam

  • Contact email

    richard.bala@uhd.nhs.uk

  • Sponsor organisation

    Tel Aviv Sourasky Medical Center

  • Duration of Study in the UK

    2 years, 0 months, 0 days

  • Research summary

    Catheter ablation is an effective and safe treatment for atrial fibrillation (AF), the commonest heart rhythm abnormality encountered clinically. Thin, flexible tubes are advanced through blood vessels to the heart and areas are destroyed by either heating, freezing or more recently using Pulsed Field Ablation (PFA) by delivering electrical pulses to cardiac tissue to produce cell death. All these techniques create scar tissue to either electrically fence off areas or knock out trouble spots causing arrhythmia.
    Ablation targeting signals from within the pulmonary veins (PVs), and isolating them from the left atrium, remains the cornerstone for AF ablation treatment. This has been highly successful in paroxysmal AF but less in persistent AF where AF maintenance may be driven by other areas within the heart. An explanation of the reduced effectiveness of PV isolation in persistent AF could be that the technologies used have not produced full thickness, durable lesions within the heart and/or other areas of the heart are involved that have not been effectively targeted. One such area is the left atrial posterior wall, the hypothesis being that electrically isolating this region may be beneficial in persistent AF but results have been mixed.
    PFA is a promising, emerging technology in the field. In contrast to thermal energies which result in discontinuous and indiscriminate lesions, PFA affects all tissues within a zone exposed to an electric field in a tissue selective manner, thereby creating long-lasting lesions and hopefully better results.
    This international multicentre study aims to address the hypothesis above for the first time in a prospective, randomised manner with follow up to 12 months. It specifically looks at the question as to whether using PFA, posterior wall isolation in addition to PV isolation in comparison to PV isolation alone adds benefit in patients with persistent AF.

  • REC name

    West Midlands - Solihull Research Ethics Committee

  • REC reference

    23/WM/0156

  • Date of REC Opinion

    19 Jul 2023

  • REC opinion

    Favourable Opinion