atrial fibrillation
Conditions
Interventions
Pulse electric field ablation group:Pulse electric field ablation
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-80 years old; 2) unlimited gender limitation; 3) first catheter ablation of non-valvular atrial fibrillation; 4) persistent atrial fibrillation lasts more than 7 days, Less than 2 years old, Including seizure termination after> 7 days by relapse (drug or electrical repetition); 5) consecutive AF with ECG / Holter / remote monitoring or implantable device recorded within 6 months prior to inclusion; 6) patients with AF-related symptoms, Including but not limited to palpitations, aura syncope / syncope, fatigue, and shortness of breath; 7) be ineffective in using one or more antiarrhythmic drugs; 8) agree to receive pulse electric field ablation, And can be follow-up as required
Exclusion criteria
Exclusion criteria: 1) Partial atrial fibrillation (AF terminated automatically or terminated by intervention within 7 days) or long-range persistent atrial fibrillation (when a rhythm control strategy is decided, Atrial fibrillation has lasted for more than 12 months); 2) patients with previous atrial fibrillation ablation; 3) previous history of left atrial surgery; 4) intracardiac thrombosis; 5) patients with pulmonary vein stenosis or pulmonary venous stent; 6) left atrial diameter> 5. 5cm (transthoracic ultrasound, transesophageal ultrasound, CT); 7) presence of other types of arrhythmias other than AF; 8) clinically significant mitral stenosis or mitral regurgitation, any heart valve prolapse or valve replacement; 9) 3 months before surgery: acute myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), cardiac surgery, heart failure hospitalization, stroke or transient ischemic attack (TIA), clinically significant bleeding events, pericardial effusion; 10) bleeding tendency, coagulation dysfunction, Or patients with any anticoagulation; 11) corrected / uncorrected severe congenital heart malformation, After atrial interval / ventricular septal defect repair / occlusion; 12) NYHA III or grade IV or left ventricular ejection fraction (LVEF) <35%; 13) second type II or tertiary atrioventricular block; 14) primary pulmonary hypertension; 15) rheumatic heart disease; 16) patients with a previous history of pericarditis; 17) patients with previous left atrial appendage occlusion / closure, Or patients with proposed left atrial appendage occlusion; 18) patients with any type of cardiac implantable electronic device (CIED); 19) hypertrophic cardiomyopathy; 20) patients with severe renal insufficiency (eGFR<30ml/min/1.73m2) or previous dialysis or renal replacement therapy;21) Currently in or planning to participate in other interventional clinical studies; 22) influencing research participation, acceptance of intervention and follow-up as judged by other researchers, Including but not limited to: the existence of CT or MRI examination contraindications; Acute systemic infection; Uncontrolled hyperthyroidism; Women of childbearing age with pregnancy or lactation or planned pregnancy; After organ or hematological transplantation or is being considered; Severe abnormal lung function; PAH; Active malignant tumors, Or receive treatment for malignant tumors in the previous 24 months (except skin squamous cell carcinoma and basal cell carcinoma); Severe psychosocial disorders affect study compliance; Life expectancy is less than 1 year; Other uncontrolled medical situations that may affect the efficacy of device treatment or increase the risk, Such as uncontrolled diabetes, untreated sleep apnea, or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate of atrial fibrillation;Pulmonary vein stenosis (stenosis degree = 70%);Phragmatic nerve injury/diaphragmatic paralysis;Atrioesophageal fistula;Cardiac tamponade/cardiac perforation;Cerebrovascular events;Major bleeding events requiring blood transfusion treatment;Myocardial infarction;Pericarditis requiring treatment;Abnormal esophageal function/gastric paresis caused by vagal nerve injury;Vascular complications that require treatment;Systemic embolism events/pulmonary embolism that require treatment;Pulmonary edema;Death;Any cardiovascular and/or pulmonary adverse events related to the PFA system or PFA surgery that result in prolonged hospitalization or require hospitalization for more than 48 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| The recurrence rate of symptomatic atrial arrhythmias without taking AAD after 12 months of surgery (3 months of blank period);;The isolation rate of immediate pulmonary vein and superior vena cava is defined as achieving complete pulmonary vein blockade during the first surgery;;Immediate posterior wall block rate;Quality of life evaluation: Changes in EQ-5D and AFEQT scores from baseline at 1, 3, 6, and 12 months after ablation surgery;The proportion of patients with severe adverse events (SAE) related to instruments or surgery;The proportion of patients with stroke or TIA;The proportion of patients who need to undergo cardiac cardioversion;The proportion of hospitalized patients with arrhythmias (AF, AT, AFL); | — |
Countries
China
Contacts
Public ContactRui Zeng
West China Hospital of Sichuan University
Outcome results
None listed