Light sedation versus general anesthesia for heart procedure in paroxysmal atrial fibrillation
Compares two anesthesia types during pulsed field ablation in adults with paroxysmal atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07877519, who can take part
Where in China
- Fuwai Hospital Chinese Academy of Medical SciencesBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- China National Center for Cardiovascular Diseases
- Trial code
- NCT07877519
- Record updated
- 26 October 2026
- Original description
This prospective, multicenter, randomized, controlled, noninferiority trial will compare local anesthesia with conscious sedation and general anesthesia in patients undergoing pulsed field ablation for paroxysmal atrial fibrillation.Read full original descriptionShow less
Efficacy and Safety of Local Anesthesia With Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Patients With Paroxysmal Atrial Fibrillation: A Prospective, Multicenter, Randomized, Controlled, Noninferiority Trial
This prospective, multicenter, randomized, controlled, noninferiority trial will compare local anesthesia with conscious sedation and general anesthesia in patients undergoing pulsed field ablation for paroxysmal atrial fibrillation.
A total of 390 participants aged 18 to 80 years will be randomly assigned in a 1:1 ratio to undergo pulsed field ablation under either local anesthesia with conscious sedation or general anesthesia. Both groups will receive pulmonary vein isolation using the same pulsed field ablation strategy.
The primary outcome is recurrence of an electrocardiographically documented atrial tachyarrhythmia after an 8-week post-ablation blanking period. Recurrence is defined as atrial fibrillation, atrial flutter, or atrial tachycardia lasting at least 30 seconds through 12 months after ablation.
The study will also compare the ability of each anesthesia strategy to support successful completion of the ablation procedure, anesthesia-related and ablation-related complications, procedural efficiency, patient-reported pain and anxiety, overall procedural experience, and direct medical costs.
Inclusion: Diagnosis of paroxysmal atrial fibrillation; Age 18 to 80 years; Scheduled and willing to undergo pulsed field ablation; American Society of Anesthesiologists physical status class I to III; Able to understand the study procedures and provide written informed consent.
Exclusion: Previous catheter ablation for atrial fibrillation or left atrial premature contractions; Concurrent participation in another clinical trial involving a drug or medical device; Known allergy to iodinated contrast media; Active infection; Contraindication to catheter ablation, including intracardiac or atrial thrombus; Pregnancy, breastfeeding, or planned pregnancy in the near future; Unwilling to participate or unable to comply with the study procedures and scheduled follow-up.