Pulsed Field Ablation vs Cryoablation for Atrial Fibrillation Under Deep Sedation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this interventional study, 60 adults with atrial fibrillation undergoing ablation are assigned 2:1 to receive either PFA or cryoballoon ablation. All procedures are performed under deep sedation with IV analgesics and sedatives; if needed, the PFA procedure can be converted to cryoballoon during the same session. The goal is to determine if deep-sedation PFA can be safely and effectively used without general anesthesia, potentially improving throughput and reducing costs. The study collects safety and efficacy data to establish a deep-sedation protocol for PFA during pulmonary vein isolation. If favorable, results could support broader adoption of deep sedation PFA in clinical practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with paroxysmal or persistent AF requiring a clinically-indicated AF ablation
* Age \>18 years old
* Able to give informed consent

Exclusion Criteria:

* Patients with a BMI \>35
* Any patient with a history of airway issues/Obstructive sleep apnoea/ obesity hypoventilation syndrome
* Significant acid reflux or presence of a large hiatus hernia
* Lack of capacity to give informed consent
* Unable to lie flat for a minimum of 45 mins

Where it's running

• Eastbourne DGH
  Eastbourne, United Kingdom Recruiting

Study contacts

• Study coordinator: Jo-Anne Taylor
• Email: esh-tr.researchanddevelopment@nhs.net
• Phone: 0300 13 14 500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.