3D-Guided Pulsed Field Ablation for Paroxysmal AF

Launched by BEIJING ANZHEN HOSPITAL · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method for a condition called paroxysmal atrial fibrillation (AF), which is an irregular heartbeat that can lead to serious problems like strokes. The trial will test a technique called pulsed field ablation (PFA), which uses high-voltage electric fields to safely and effectively treat AF. The goal is to improve the procedure by using a 3D guidance system, which could make it easier and safer for patients. Researchers aim to enroll 430 participants to see how well this method works over one year.

To participate, you must be at least 18 years old and have paroxysmal atrial fibrillation that requires treatment. However, there are certain health conditions that might exclude you from joining, such as severe heart problems or prior heart surgeries. If you are eligible and decide to join, you can expect to receive the PFA treatment under careful monitoring, and you will follow up with the medical team for a year to track your progress and any potential side effects. This trial is an important step towards improving AF treatments and developing new technologies for patients in China.

Gender

ALL

Eligibility criteria

• • \*\*Inclusion Criteria:\*\*
• • 1. Aged 18 years or older, regardless of gender.
• • 2. Patients with paroxysmal atrial fibrillation scheduled for catheter ablation.
• • 3. Willing and able to comply with all follow-up requirements and agree to participate in this study.
• • \*\*Exclusion Criteria:\*\*
• • 1. Previous left atrial catheter ablation.
• • 2. Left ventricular ejection fraction (LVEF) \< 35%.
• • 3. Left atrial diameter (assessed by echocardiography) \> 55 mm.
• • 4. Presence of definite thrombus in the left atrium or any other cardiac chamber detected before surgery.
• • 5. Patients with New York Heart Association (NYHA) functional class III-IV heart failure.
• • 6. Patients with second-degree (Type II) or third-degree atrioventricular block.
• • 7. Significant congenital heart defects (e.g., atrial septal defect or severe pulmonary vein stenosis, but not including patent foramen ovale).
• • 8. Patients with prosthetic heart valves.
• • 9. Patients with implanted cardiac pacemakers or implantable cardioverter-defibrillators (ICDs).
• • 10. Patients diagnosed with hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, or myxoma.
• • 11. Patients with known symptomatic carotid artery stenosis before surgery.
• • 12. Patients with untreated or uncontrolled hyperthyroidism or hypothyroidism.
• • 13. Patients with systemic active infections.
• • 14. Patients with significant bleeding tendencies or those undergoing hemodialysis for renal failure.
• • 15. Patients who have experienced a myocardial infarction or undergone any cardiac intervention/open-heart surgery within the past 3 months.
• • 16. Patients who have had a stroke or transient ischemic attack within the past 6 months.
• • 17. Patients with significant contraindications to interventional procedures, as determined by the investigator, who are unable to undergo ablation surgery.
• • 18. Pregnant or breastfeeding women, or those planning to conceive during the study period.
• • 19. Patients who have participated in other drug or medical device clinical trials within the past 3 months.
• • 20. Patients whom the investigator deems unsuitable for participation in this clinical trial.