Clinical Trial

Remimazolam-Fentanyl Mild Conscious Sedation Regimen in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation

Study acronym: ReFeR-PFA
Recruiting
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Record status
This record was last updated July 29, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This prospective single-arm study will evaluate whether mild conscious sedation using remimazolam with fentanyl is a feasible alternative to deeper sedation or general anaesthesia during FARAPULSETM pulsed-field ablation for paroxysmal atrial fibrillation, with careful periprocedural monitoring and assessment of both sedation-related safety outcomes and patient-reported procedural experience.
Trial Details
NCT Number NCT07734194
Lead Sponsor Charles University, Czech Republic
Conditions Atrial Fibrillation (AF)
Enrollment 20 participants
Start Date 2026-01-01
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-29