Paroxysmal atrial fibrillation
Conditions
Interventions
Pulsed field ablation (PFA) group:pulmonary vein isolation with PFA
Sponsors
Fuwai Hospital, CAMS & PUMC
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age range: 18-75 years old (inclusive); 2) Clinically diagnosed as symptomatic, drug-resistant paroxysmal atrial fibrillation; 3) Plan to perform atrial fibrillation ablation surgery with the goal of pulmonary vein isolation (PVI); 4) Voluntarily participated in this experiment and signed the informed consent form; 5) Willing to comply with the relevant requirements of this experiment and cooperate in completing the corresponding follow-up.
Exclusion criteria
Exclusion criteria: 1) Atrial fibrillation caused by electrolyte imbalance, thyroid disease, reversible or non cardiac reasons; 2) Clearly identify subjects who require ablation therapy in areas outside of the pulmonary vein and superior vena cava, such as the tricuspid isthmus (CTI) region, for the treatment of supraventricular tachycardia (such as atrioventricular reentry tachycardia, atrioventricular nodal reentry tachycardia, etc.), ventricular tachycardia, and Wolff Parkinson White syndrome; 3) The clinical diagnosis is persistent atrial fibrillation (duration>7 days) or long-term persistent atrial fibrillation or permanent atrial fibrillation; 4) Subjects who did not use antiarrhythmic drugs (AAD) for effective control of paroxysmal atrial fibrillation before surgery; 5) Severe left atrial enlargement (left atrial anterior posterior diameter>50mm); 6) Left ventricular ejection fraction (LVEF)8cm2); 8) Subjects who have undergone left atrial catheter ablation surgery or surgical procedures in the past; 9) Subjects who have undergone heart related surgeries such as atrial/ventricular incision, atrial septal defect repair, patent foramen ovale closure, left atrial appendage closure, or heart valve related surgeries such as heart valve repair/replacement and are not suitable for catheter ablation in the past; 10) Subjects who plan to undergo cardiac related surgeries such as heart transplantation, left atrial appendage occlusion, permanent pacemaker implantation, or other major surgeries that affect ablation therapy within the next 12 months; 11) Subjects with significant congenital abnormalities in cardiac anatomy that hinder the entry of ablation catheters into the target ablation area; 12) Subjects with intracardiac thrombosis, myxoma, atrial patch, occluder or other conditions that hinder catheter insertion or operation; 13) Subjects with implantable pacemakers, implantable cardiodefibrillators (ICDs), or other implantable metal cardiac devices that may interfere with the pulse energy field; 14) Subjects with severe lung diseases (such as restrictive pulmonary disease, chronic obstructive pulmonary disease) or other lung diseases or functional impairments that cause serious chronic symptoms, such as significant pulmonary vein abnormalities, pulmonary vein stenosis, etc., that hinder ablation therapy; 15) Subjects with serious obstruction of vascular access (such as implanted inferior vena cava filters, intramural thrombosis, etc.); 16) Subjects with severe coagulation dysfunction, bleeding tendency, or contraindications to anticoagulant drugs such as heparin, warfarin, or dabigatran; 17) Subjects with active systemic infections; 18) Uncontrollable hypertension (sustained systolic blood pressure = 180mmHg or sustained diastolic blood pressure = 110mmHg); 19) Subjects with severe liver and kidney dysfunction; 20) Screening subjects with a history of systemic thromboembolism (including TIA) within the previous month; 21) Select subjects with unstable angina or those who have experienced acute myocardial infarction within the previous 3 months; 22) Select subjects who have undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the previous 3 months; 23) Subjects who are currently participating in clinical studies of other devices or drugs before screening; 24) Female participants of childbearing age who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long term ablation success rate ;The incidence of major adverse events within 7 days after ablation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate system success and availability success;Success rate of acute ablation;The incidence of esophageal injury with clinical symptoms; | — |
Countries
China
Contacts
Public ContactMin Tang
Fuwai Hospital, CAMS & PUMC
Outcome results
None listed