Clinical Research Directory

A Comparison of Pulsed Field Ablation (PFA) vs Cryoablation for Atrial Fibrillation Under Deep Sedation

Sponsor: East Sussex Healthcare NHS Trust

Summary

Pulsed Field Ablation (PFA) has created a 'paradigm shift' within cardiac electrophysiology and the initial experience demonstrates that PFA is safe, rapid and effective compared to both radiofrequency ablation and cryoablation in atrial fibrillation (AF). Presently, AF ablation procedures in the UK using PFA are routinely performed using general anaesthetic (GA) support requiring an anaesthetist and ODP being present in all procedures. This need significantly limits the ability to use PFA technology to perform AF ablations, particularly in centres that have limited availability of GA provision. The need for GA also leads to extended patient recovery time post procedure which impacts patient throughput and has the potential to reduce hospital bed availability. The need for GA and the potential to limit patient throughput has negative implications for all hospitals in terms of cost. PFA procedures performed elsewhere in Europe use deep sedation with IV propofol led by the ablating physician, but this is not permitted in the UK and still requires the presence of an anaesthetist. The investigators will aim to evaluate if AF ablation using PFA is feasible during spontaneous respiration without the use of propofol. The investigators will conduct a non-randomized study comparing AF ablation using PFA vs cryoballoon under deep sedation - aiming to demonstrate that \>75% of patients can complete the PFA protocol under deep sedation without conversion to cryoballoon (due to patient intolerance). The principal aim of the study is therefore not to demonstrate superiority or comparative efficacy of one ablation modality over another but rather the ability and feasibility to deliver pulsed field ablation under deep sedation. The use of cryoablation serves as a benchmark comparator to contextualise procedural and sedation-related observations.

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