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

RecruitingNAAges 18 Years - 80 YearsAllChina National Center for Cardiovascular Diseases
NCT07877519 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 supp

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📋 Eligibility rules (as published)
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.
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What it tests

  • Local Anesthesia With Conscious Sedation
  • General Anesthesia
  • VARIPULSE Pulsed Field Ablation System
  • Compound methoxyphenamine capsules
  • Salbutamol
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Where

1 site
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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