Rationale and Design of the InsightPFA Trial

This study is a mulitcentre, randomized, parallel-group evaluation of pulse field ablation(PFA) and radiofrequency ablation(RFA) in patients being treated for symptomatic paroxysmal AF.

Pulmonary-vein isolation (PVI) is the primary intention of catheter ablation in both groups.

Patients are randomized to either pulse field ablation(PFA) using the PFA catheters(Insight Medtech) or radiofrequency ablation(RFA) using the RFA catheters（Biosense Webster).During the ablation procedure, the (1:1) randomly selected ablation modality is used in the left atriuablation procedurem to electrically isolate the pulmonary veins (PVs).All investigators demonstrates the success of PVI by the abolition of conduction of atrial impulses into the PVs.

Additional LA linear lesions or complex fractionated atrial electrogram ablation(s) are not allowed, and adenosine testing not performed, in either group. Concomitant ablation of previously documented avotricuspid isthmus-dependent atrial flutter (AFL) is allowed at the ablation procedure in both groups.

The acute procedural end point is defined as the absence or dissociation of all PV potentials, as confirmed by bi-directional block using a circular mapping catheter after a 20 min waiting period (subsequent to the last ablation).

Randomized groups are held throughout the trial, and re-ablation during the 3-month blanking period is allowed if the re-ablation is performing with the same type of catheter used at the ablation procedure. During the 3-month blanking period, antiarrhythmic drug (AAD) administration is allowed, but amiodarone iscontinuation is required at the time of the ablation procedure. Beta-adrenergic blockers is permitted and can be used at any time during this trail.

The primary efficacy endpoint is the 12-month treatment success rate，defining as the use of no class I or III AAD and no AF/AFL/AT episodes between the time of ablation blank (within 3 months after the ablation procedure) and 12 months of follow-up. (Confirmed by a definite ECG or dynamic ECG).

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old ≤ age ≤ 75 years old, gender is not limited;
2. Patients with symptomatic paroxysmal atrial fibrillation confirmed by electrocardiogram or clinically diagnosed；
3. Catheter ablation of atrial fibrillation is planned;
4. Agree to participate in this clinical trial, and voluntarily sign an informed consent form, and are willing to complete relevant inspections and follow-up visits in accordance with the requirements of the protocol.

Exclusion Criteria:

1. Previous surgery or catheter ablation for atrial fibrillation;
2. The clinical diagnosis is persistent or long-term persistent atrial fibrillation;
3. Patients with left ventricular ejection fraction (LVEF) \<40%, or patients with NYHA cardiac function class III and IV;
4. Left atrial diameter (echocardiography) ≥ 50mm;
5. Imaging examination results suggest left atrium or left atrial appendage thrombus;
6. There is a history of anticoagulation contraindications, abnormal blood coagulation or bleeding;
7. Patients with acute/active systemic infection;
8. Severe lung disease, pulmonary hypertension, or any lung disease involving severe dyspnea such as blood gas abnormalities;
9. Clinically diagnosed as hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, known or suspected atrial myxoma;
10. Previous heart valve repair or replacement or artificial valve implantation; previous history of atrial septal defect closure, patent foramen ovale closure cardiac intervention or surgery;
11. Patients with cardioverter-defibrillators or other active implanted devices implanted in their bodies;
12. Myocardial infarction, unstable angina pectoris or any cardiac intervention/open surgery (except coronary angiography examination) occurred within 3 months; hospitalization due to heart failure, stroke (except asymptomatic stroke) within 3 months ) or transient ischemic attack;
13. Received any carotid artery stent placement or endarterectomy within 6 months;
14. Patients who have obvious contraindications to interventional surgery and are judged by the investigator to be unable to undergo ablation surgery;
15. Participated in clinical trials of other drugs or devices during the same period;
16. Life expectancy is less than 12 months (such as advanced malignant tumor);
17. Women who are pregnant or breastfeeding or those who have family planning during the trial;
18. Other circumstances considered by the investigators to be inappropriate to participate in this clinical trial.