NCT07877519Recruiting
Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 390 (estimated)
- First submitted
- 19 Jul 2026
- Start date
- 1 Jun 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- Atrial fibrillation
- NCT number
- NCT07877519
What you commit to
- Study type: Interventional
- Planned participants: 390
- From 1 Jun 2026 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous catheter ablation for atrial fibrillation or left atrial premature contractions.
- Concurrent participation in another clinical trial involving a drug or medical device.
Other illness
- Known allergy to iodinated contrast media.
- Active infection.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.