Paroxysmal atrial fibrillation
Conditions
Interventions
Pulsed Field Ablation Group (PFA):Pulsed Field Ablation
Robotically Navigated Magnetic-guided Radiofrequency Ablation Group (RMN-RF group):Robotically Navigated Magnetic-guided Radiofrequency Ablation
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 years and <80 years; 2.Diagnosed with paroxysmal atrial fibrillation and meets indications for ablation therapy; 3.Planned to undergo first-time atrial fibrillation ablation procedure; 4.Able to provide written informed consent and willing to comply with all follow-up visits and related examinations.
Exclusion criteria
Exclusion criteria: 1.Contraindications to PFA procedure or anticoagulant medications; 2.Previous atrial fibrillation ablation procedure or cardiac surgery; 3.Occurrence of acute myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, cardiac surgery, or hospitalization for heart failure within 3 months prior to the procedure; 4.Severe renal dysfunction (eGFR <30 ml/min/1.73 m^2) or history of dialysis/renal replacement therapy; 5.Life expectancy <1 year; 6.Pregnant or breastfeeding women; 7.Other conditions deemed by the investigator as unsuitable for participation in this study (e.g., severe liver disease, coagulation disorders, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of pulmonary vein electrical conduction recovery within 20 minutes post-procedure (calculated per pulmonary vein, for non-inferiority testing); | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-procedure cardiac PET-MRI assessment;1-year treatment success rate (atrial fibrillation/atrial flutter/atrial tachycardia recurrence defined as ECG recording >=10 seconds or Holter monitoring >=30 seconds);Ablation lesion area at 10 and 20 minutes post-procedure in the PFA group;Proportion of pulmonary vein electrical conduction recovery within 20 minutes post-procedure (for superiority analysis);Proportion of pulmonary vein electrical conduction recovery at 0–10 minutes and 10–20 minutes post-procedure;1-year treatment success rate in subjects with versus without acute reconnection;Procedure-related parameters (total procedure time, total operating room time, left atrial dwell time);Incidence of major serious adverse events; | — |
Countries
China
Contacts
Public ContactQI Jin
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed