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Active Not Recruiting NCT07541339

Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation

Conditions: Atrial Fibrillation (Paroxysmal)

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 224
Sponsor: Beijing Anzhen Hospital

Location: Beijing Anzhen Hospital Beijing Beijing Municipality

Summary

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

Eligibility Criteria

Inclusion Criteria: * 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 * Provide written informed consent for study participation and be able to complete all scheduled follow-up assessments Exclusion Criteria: * 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 \

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Source: ClinicalTrials.gov (NCT07541339). StuddyBuddy aggregates publicly available trial information.