Single-Use Spherical Pulsed Ablation Catheter for Paroxysmal Atrial Fibrillation

A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial Evaluating the Safety and Efficacy of Cardiac Pulsed Field Ablation Devices Combined With Single-use Spherical Pulsed Ablation Catheters in Treating Paroxysmal Atrial Fibrillation

The goal of this clinical trial is to learn if the cardiac pulsed field ablation system, composed of the cardiac pulsed field ablation device, the single-use spherical pulsed ablation catheter, and the optional cardiac three-dimensional mapping system, works to treat symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation. It will also learn about the safety of this set of investigational medical devices. The main questions it aims to answer are:

Does the combination of the cardiac pulsed field ablation device and the single-use spherical pulsed ablation catheter improve the 12-month post-procedure treatment success rate for participants with paroxysmal atrial fibrillation? What adverse events and medical problems do participants experience after receiving the investigational pulsed field ablation treatment? Researchers will compare the investigational pulsed field ablation therapy to the clinically recognized radiofrequency ablation therapy using the marketed Diagnostic/Ablation Deflectable Tip Catheter to verify the non-inferior effectiveness and safety of the test devices for treating paroxysmal atrial fibrillation.

Participants will:

Undergo screening assessments within 14 days before the procedure, including signing informed consent, completing medical history collection, physical vital sign checks, laboratory tests, 12-lead ECG, echocardiogram, baseline quality of life score evaluation, and confirmation of meeting all inclusion criteria without any exclusion criteria Be randomly assigned to either the investigational pulsed field ablation group or the control radiofrequency ablation group on the day of surgery Receive the assigned ablation procedure, with intra-operative recordings of core surgical parameters, pain score assessment, and investigational device performance evaluation Complete post-procedure assessments before discharge (within 7 days after surgery), including post-operative laboratory tests, pain follow-up, and recording of re-ablation, electrical cardioversion, readmission events, adverse events and concomitant medications Return for follow-up visits or complete telephone follow-ups at 1 month (±7 days), 3 months (±15 days), 6 months (±30 days) and 12 months (±30 days) after the procedure, which include physical vital sign checks, remote ECG monitoring (daily for the first 3 months after surgery, weekly from month 4 to month 12, and as needed when symptoms occur), 72-hour Holter and 12-lead ECG tests at the 6-month and 12-month visits, echocardiogram reexamination, repeated quality of life scoring, and continuous recording of arrhythmia recurrence, subsequent treatment events, adverse events and medication status Keep a symptom and ECG monitoring diary for the entire 12-month follow-up period after the procedure, as required by the trial protocol

Inclusion Criteria:

• Age ≥18 years and ≤75 years, without gender restriction
• Patients with symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation
• Subjects scheduled for atrial fibrillation catheter ablation
• Subjects who agree to participate in this study and voluntarily sign the informed consent form

Exclusion Criteria:

• Persistent atrial fibrillation, or atrial fibrillation secondary to electrolyte disturbance, thyroid disease, alcohol or other reversible/non-cardiac causes
• Anterior-posterior left atrial diameter (measured by MRI, CT or TTE) ≥55 mm
• Prior history of any atrial surgery or atrial endocardial/epicardial ablation, except cavotricuspid isthmus ablation or right-sided supraventricular tachycardia ablation
• Existing left atrial thrombus, atrial myxoma, atrial septal patch or shunt device
• Prior or planned concomitant left atrial appendage closure procedure at index procedure
• Diagnosis of hypertrophic cardiomyopathy
• History of congenital heart disease with residual anatomical or conduction abnormalities
• Hemodynamically significant valvular heart disease judged by investigator to be ineligible for enrollment
• Prior valve repair or valve replacement surgery
• Implanted pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy device
• NYHA functional class Ⅲ-Ⅳ
• Left ventricular ejection fraction (LVEF) ≤40%
• Symptomatic hypotension or uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg in two baseline measurements)
• Symptomatic resting bradycardia or type-second-degree or third-degree atrioventricular block
• Contraindication to systemic anticoagulation, or unwillingness to receive systemic anticoagulation
• Medical conditions that may interfere with study participation, assessment or treatment, significantly increase study-related risk, or alter study outcomes, including but not limited to: moderate-to-severe COPD, moderate-to-severe pulmonary hypertension, or diseases causing severe dyspnea or resting hypoxemia; renal insufficiency (eGFR<30 ml/min/1.73 m²) or history of hemodialysis or renal transplantation; active malignancy or treated malignancy within 24 months prior to enrollment (excluding basal cell or squamous cell skin carcinoma); active systemic infection
• Myocardial infarction, unstable angina, heart failure hospitalization within 3 months prior to enrollment; any cardiac interventional or open-heart surgery within 1 month prior to enrollment (coronary angiography excluded)
• Stroke (excluding silent stroke), transient ischemic attack or any thromboembolic event within 3 months prior to enrollment
• Expected survival less than 1 year
• Female subjects who are pregnant, lactating, or planning pregnancy during study period
• Participation in another interventional device clinical trial within 1 month before enrollment, or within 5 half-lives of last study drug for drug clinical trials
• Any other condition judged by investigator to make the subject unsuitable for this clinical trial