InsightPFA Trial of the LotosPFA Catheter

Korábbi kezelés

• History of prior surgery or catheter ablation for atrial fibrillation (AF);
• 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;
• Participation in other drug or device clinical trials concurrently;

Más betegség

• 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;
• 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;
• Life expectancy of less than 12 months due to conditions such as advanced malignancy;

Laborértékek

• Left ventricular ejection fraction (LVEF) < 40% or New York Heart Association (NYHA) functional class III or IV;

Egyéb

• Clinical diagnosis of persistent or long-standing persistent AF;
• Left atrial diameter (as measured by echocardiography) ≥ 50 mm;
• Imaging findings suggestive of left atrial or left atrial appendage thrombus;
• Presence of an implanted cardioverter defibrillator or other active implanted devices;
• 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;
• 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

• 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..