This study is a prospective, single-center, single-arm clinical trial planning to screen and enroll 200 subjects. It aims to evaluate the efficacy and safety of pulsed field ablation (PFA) using the FARAPULSE™ system for pulmonary vein isolation (PVI) and superior vena cava isolation (SVCI) in Chinese patients with paroxysmal atrial fibrillation (PAF). Baseline preoperative data, along with intraoperative and postoperative follow-up information, will be collected. The primary endpoint is the proportion of subjects achieving successful PVI and SVCI using solely the FARAPULSE™ PFA system. Secondary endpoints include long-term procedural success rates and various procedural parameters. Additionally, the incidence of adverse events will be recorded as safety endpoints. The study adopts a single-arm target value design hypothesis, and research data will also be compared with historical data from patients treated with radiofrequency ablation for PVI and SVCI to further evaluate the efficacy of PFA. Subgroup analysis will be conducted in patients with heart failure to assess the efficacy and safety of PFA in this population.
Age between 18 and 75 years.
Documented diagnosis of paroxysmal atrial fibrillation (PAF), defined as typical AF electrographic characteristics (absence of P waves with irregular fibrillatory waves) recorded on 12-lead ECG or symptomatic Holter monitoring, with each episode lasting less than 7 days.
Symptomatic despite attempted antiarrhythmic drug therapy.
Scheduled to undergo initial catheter ablation procedure.
AF secondary to electrolyte imbalance, thyroid disorders, or other reversible/non-cardiac causes.
Persistent atrial fibrillation.
Presence of persistent left superior vena cava.
Contraindications to pulsed field ablation (e.g., left atrial appendage thrombus, post-atrial septal defect device closure, permanent metallic implants in the left atrium) or contraindications to anticoagulant therapy.
Single group
Pulsed Field Ablation
DevicePulsed Field Ablation
PVI and SVCI
The proportion of subjects achieving successful PVI and SVCI using solely the FARAPULSE™ PFA system
Long-term procedural success rates
The percentage of subjects, among the total enrolled, who remained free of recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia, with any episode lasting \>10 seconds on standard ECG or \>30 seconds on Holter monitoring.
Perioperative complications
Serious bradyarrhythmia requiring permanent pacemaker implantation, cardiac tamponade/cardiac perforation, thromboembolic events, severe coronary artery spasm (\>90% stenosis), phrenic nerve palsy, acute hemolysis and hemolysis-induced renal failure, vascular access complications requiring surgical or interventional management, atrioesophageal fistula, pulmonary vein stenosis, and death.
Total procedure time
The duration from femoral venous puncture until the removal of all devices from the body
Anesthesia induction time
The duration from the administration of anesthetic agents until achieving a satisfactory anesthetic state (allowing initiation of the procedure)
Left atrial operation time
The duration from the entry of the ablation catheter into the left atrium until its withdrawal from the left atrium
Right atrial operation time
The duration from the withdrawal of the ablation catheter from the left atrium until its complete removal from the body
Click on the lead sponsor to view all of their trials.
Shanghai Zhongshan Hospital
Lead sponsor
Boston Scientific Corporation
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
