The goal of this clinical trial is to compare the safety and efficacy of conscious sedation and general anesthesia in patients with paroxysmal atrial fibrillation undergoing their first pulsed-field ablation (PFA) procedure. It will also establish a scalable conscious sedation protocol for PFA. The main questions it aims to answer are:
1. Does conscious sedation reduce the incidence of the composite safety endpoint (persistent hypotension or hypoxemia for more than 60 seconds intraoperatively) compared with general anesthesia? 2. What are the differences in perioperative indicators and adverse events between the two anesthetic strategies in PFA for paroxysmal atrial fibrillation? Researchers will randomly assign eligible patients to a conscious sedation group or a general anesthesia group at a 1:1 ratio to compare the safety and efficacy of the two anesthetic approaches.
Participants will:
1. Receive the assigned anesthetic strategy combined with standardized PFA procedure 2. Complete intraoperative vital sign and related index monitoring 3. Undergo follow-up visits at 12-24 hours, 30 days and 90 days after surgery for relevant index assessment and adverse event recording
Aged 18 to 80 years
Diagnosed with paroxysmal atrial fibrillation
No prior history of catheter ablation for atrial fibrillation/atrial flutter
Scheduled to undergo pulsed-field ablation
Obstructive sleep apnea-hypopnea syndrome (OSAHS)
Complicated with severe chronic obstructive pulmonary disease (COPD), asthma or other respiratory system diseases
Body mass index (BMI) >30 kg/m² or <20 kg/m²
Preoperative pulse oxygen saturation (SpO₂) <93%