Clinical Trial

Deep Sedation in Catheter Ablation of Atrial Fibrillation

Study acronym: PRIORI-AF
Not Yet Recruiting
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Summary
The current practice of anesthesia for atrial fibrillation catheter ablation (CA) procedure is inconsistent, including general anesthesia, deep sedation, and conscious sedation.Due to the nature of deep sedation, it has been continuously gaining its position as one of the crucial components in standard practices of atrial fibrillation ablation during the last decade. Currently, a considerable number of procedures have been done using conscious sedation. Previous studies explored the benefits obtained from the employment of deep sedation in AF ablation procedures, mainly focused on pain reduction and intra-procedural safety. However, the benefits on long-term rhythmic outcomes, peri-procedural safety as well as benefits on procedural parameters and peri-procedural experiences from patients/ablators/lab staff have yet not to be thoroughly studied. We plan to conduct a prospective, multicenter, randomized, controlled trial to evaluate the benefits of deep sedation in catheter ablation of paroxysmal and persistent AF in multiple prospective, i.e., quantified intraprocedural patients / physicians / lab staffs / mapper clinical specialist experiences, and the procedure safety.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-02-16.
Trial Details
NCT Number NCT06836999
Lead Sponsor The First Affiliated Hospital of Dalian Medical University
Conditions Atrial Fibrillation, Atrial Fibrillation, Paroxysmal or Persistent, Deep Sedations, Conscious Sedation
Enrollment 1,334 participants
Start Date 2025-03-03
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-04