Conscious Sedation vs General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized noninferiority trial enrolling 390 adults with paroxysmal atrial fibrillation. Participants are assigned 1:1 to undergo pulsed field ablation under either local anesthesia with conscious sedation or general anesthesia, using the same ablation strategy. The primary outcome is recurrence of atrial tachyarrhythmia lasting at least 30 seconds within 12 months after an 8-week blanking period. The study also assesses whether each anesthesia approach supports successful procedure completion and related safety. Pulsed field ablation can cause chest discomfort, coughing, or nerve stimulation, which may influence anesthesia choice and procedural stability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of paroxysmal atrial fibrillation.
2. Age 18 to 80 years.
3. Scheduled and willing to undergo pulsed field ablation.
4. American Society of Anesthesiologists physical status class I to III.
5. Able to understand the study procedures and provide written informed consent.

Exclusion Criteria:

1. Contraindication to catheter ablation, including intracardiac or atrial thrombus.
2. Previous catheter ablation for atrial fibrillation or left atrial premature contractions.
3. Known allergy to iodinated contrast media.
4. Concurrent participation in another clinical trial involving a drug or medical device.
5. Pregnancy, breastfeeding, or planned pregnancy in the near future.
6. Active infection.
7. Unwilling to participate or unable to comply with the study procedures and scheduled follow-up.

Where it's running

• Fuwai Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Guanzhi Chen, Doctor
• Email: chenguanzhi@fuwai.com
• Phone: +8613923975318

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.