What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Catheter ablation, Deep sedation with midazolam and fentanyl or midazolam and remifentanil, or Sedation with midazolam and fentanyl. The registry lists allocation as randomized. 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).
They plan to enroll about 60 people at Eastbourne. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.
Official title (unrewritten)
A Comparison of Pulsed Field Ablation (PFA) vs Cryoablation for Atrial Fibrillation Under Deep Sedation
Interventions: Catheter ablation, Deep sedation with midazolam and fentanyl or midazolam and remifentanil, Sedation with midazolam and fentanyl
Primary outcome (registry wording): Percentage of patients able to complete protocol with pulsed field ablation without conversion to cryoablaton