InsightPFA Trial of the LotosPFA Catheter

The InsightPFA trial is a prospective, multicenter, randomized controlled trial to compare the effectiveness and safety of PFA versus RFA for PVI in Chinese patients with symptomatic paroxysmal AF. Two hundred and ninety-two patients diagnosed with symptomatic paroxysmal AF will be randomly assigned to either the PFA group or the RFA group in a 1:1 ratio. All subjects will undergo PVI using PFA or AI guided RFA and be followed up to 12 months. The primary endpoint is defined as freedom from any episodes of AF/AFL/AT without Class I or III antiarrhythmic drugs during the 9-month follow-up period after a 90-day blank period. The secondary endpoints of effectiveness include acute treatment success and procedural data. The safety evaluation includes a composite of death, stroke and transient ischemic attack, procedure-related complications, device-related adverse events, and serious adverse events. A noninferiority comparison will be conducted between the novel PFA system and the existing RFA system in terms of both effectiveness and safety.

Inclusion criteria

• Age between 18 and 75 years, of either sex.
• Patients with ECG-confirmed or clinically definite diagnosis of symptomatic paroxysmal atrial fibrillation (PAF).
• Scheduled to undergo catheter ablation for atrial fibrillation
• Willing to participate in this clinical trial, voluntarily sign the informed consent form, and commit to completing required examinations and follow-ups per protocol..

Exclusion criteria

• History of prior surgery or catheter ablation for atrial fibrillation (AF);
• Clinical diagnosis of persistent or long-standing persistent AF;
• Left ventricular ejection fraction (LVEF) < 40% or New York Heart Association (NYHA) functional class III or IV;
• Left atrial diameter (as measured by echocardiography) ≥ 50 mm;
• Imaging findings suggestive of left atrial or left atrial appendage thrombus;
• Contraindications to anticoagulation therapy, including a history of blood clotting disorders or abnormal bleeding;
• Presence of acute or active systemic infection;
• Significant lung disease, pulmonary hypertension, or any lung condition associated with severe dyspnea, such as abnormal blood gases;
• Clinical diagnosis of hypertrophic cardiomyopatly, chronic obstructive pulmonary disease (COPD), or known/suspected atrial myxoma;
• History of previous heart valve repair or replacement, implantation of a prosthetic valve, or previous cardiac interventions such as atrial septal defect closure or patent foramen ovale closure;
• Presence of an implanted cardioverter defibrillator or other active implanted devices;
• Myocardial infarction, unstable angina, or any cardiac intervention/open surgery (excluding coronary angiography) within the past 3 months; hospitalization for heart failure, stroke (excluding silent stroke), or transient ischemic attack within the past 3 months;
• Any carotid stenting or endarterectomy performed within the past 6 months;
• Patients who have clear contraindications to interventional procedures, rendering them unsuitable for the ablation procedure in the judgment of the investigator;
• Participation in other drug or device clinical trials concurrently;
• Life expectancy of less than 12 months due to conditions such as advanced malignancy;
• Women who are pregnant, breastfeeding, or planning to conceive during the trial period;
• Any other situations deemed inappropriate for participation in the clinical trial as determined by the investigator