CONSCIOUS-PFANCT07900685

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

StatusRecruiting

PhaseNot applicable

SponsorEast Sussex Healthcare NHS Trust

Primary completionApr 1, 2028 (estimated)

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Record History

All 1 version: 1 with changes below.

Oct 21, 2026 Study First Submitted

Endpoints

Primary

Percentage of patients able to complete protocol with pulsed field ablation without conversion to cryoablaton

Timeframe: 18 months

Secondary (3)

Numeric Rating scale for pain - Pain severity index (PSI)

- Patient Experience Questionnaire for post-procedural pain, discomfort - Visual Analogue Scale (VAS) - Atrial Fibrillation Specific Patient Reported Outcome Measures Questionnaire (AF-PROMs) questionnaire

- Lab occupancy time/ skin-to-skin time

Arms and interventions

Pulsed field ablation group under deep sedationExperimental

Cryoablation group under sedationActive comparator

Devices: Catheter ablation

Drugs: Deep sedation with midazolam and fentanyl or midazolam and remifentanil, Sedation with midazolam and fentanyl

Sites

1 site in 1 country

Eastbourne DGHEastbourne, United Kingdom

About this trial

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.

Trial details

Enrollment: 60 participants (estimated)
Started: Oct 19, 2026
Study completion: Oct 1, 2028 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, non-randomized, open label, treatment
Oversight: No data monitoring committee
Conditions: Atrial Fibrillation, Atrial Fibrillation (AF)
First posted: Oct 28, 2026
Registry updated: Oct 28, 2026
Last verified: Oct 2026

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