Deep Sedation in Catheter Ablation of Atrial Fibrillation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Dalian Medical University

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

has received CA procedure for AF or atrial septal defect repair before enrollment

left atrial diameter (LAD) ≥55 mm or thrombosis in the left atrium;

eGFR<30mL/min/1.73㎡

a history of cerebrovascular disease within the last three months (including stroke and transient ischemic attack [TIA])

Trial design

Treatments tested in this trial

  • deep sedation
  • Conscious sedation

Treatment groups

1,334 Participants
are divided into 2 treatment groups