Atrial Fibrillation (Paroxysmal)
Conditions
Brief summary
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.
Interventions
DEVICEPulsed Field Ablation
Pulsed Field Ablation
Sponsors
Boston Scientific Corporation
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Voluntarily provided written informed consent.
Exclusion criteria
* 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. * Unsuitable for deep sedation/anesthesia per operator assessment. * Life expectancy less than 1 year. * Other conditions deemed inappropriate for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PVI and SVCI | Periprocedural | The proportion of subjects achieving successful PVI and SVCI using solely the FARAPULSE™ PFA system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term procedural success rates | From the end of the 3-month blanking period post-ablation to the 12-month follow-up | 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 | From the end of the ablation to the 12-month follow-up | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Right atrial operation time | Periprocedural | The duration from the withdrawal of the ablation catheter from the left atrium until its complete removal from the body |
| Total procedure time | Periprocedural | The duration from femoral venous puncture until the removal of all devices from the body |
| Number of ablations | Periprocedural | Total number of ablations, number of ablations for pulmonary vein isolation, and number of ablations for superior vena cava isolation. |
| Anesthesia induction time | Periprocedural | The duration from the administration of anesthetic agents until achieving a satisfactory anesthetic state (allowing initiation of the procedure) |
| Left atrial operation time | Periprocedural | The duration from the entry of the ablation catheter into the left atrium until its withdrawal from the left atrium |
Contacts
Primary ContactChunfeng Dai, M.D.
Outcome results
None listed