Persistent Atrial Fibrillation
Conditions
Interventions
PVI-Alone Group:Pulmonary Vein Isolation Using Pulsed Field Ablation
PVI Plus SVCI Group:Pulmonary Vein Isolation Plus Superior Vena Cava Isolation Using Pulsed Field Ablation
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Persistent atrial fibrillation of less than 1 year in duration; 2.Age between 18 and 75 years; 3.Voluntary participation in the study, with the capacity to understand the study information, provision of written informed consent, and willingness and ability to complete the protocol-specified postoperative follow-up;
Exclusion criteria
Exclusion criteria: 1.Significant cardiac functional or structural abnormality, defined as a left ventricular ejection fraction of less than 50% or a left atrial anteroposterior diameter of greater than 46 mm; 2.Previous left atrial ablation or cardiac surgery, including left atrial appendage occlusion; 3.Presence of a permanent pacemaker, cardiac resynchronization therapy device, implantable cardiac monitor, or any type of implantable cardioverter-defibrillator. 4.Previous pulmonary vein stenting, pulmonary vein stenosis, or superior vena cava stenosis. 5.Previous unilateral phrenic nerve paralysis; 6.Presence of any prosthetic heart valve or moderate-to-severe Grade 3–4 valvular regurgitation or stenosis; 7.Any cardiac surgery, myocardial infarction, percutaneous coronary intervention, percutaneous transluminal coronary angioplasty, or coronary stent implantation within 3 months before signing informed consent. 8.Unstable angina, New York Heart Association Class III or IV heart failure, primary pulmonary hypertension, rheumatic heart disease, or hypertrophic cardiomyopathy; 9.Thrombocytosis, thrombocytopenia, any condition precluding long-term anticoagulation, or active systemic infection; 10.Atrial fibrillation caused by a reversible condition, such as hyperthyroidism; 11.Stroke or transient ischemic attack within 6 months before signing informed consent. 12.Pregnancy or breastfeeding; 13.Life expectancy of less than 1 year. 14.Current or anticipated participation in another clinical trial involving a drug, medical device, or biological product during the study period; 15.Intracardiac thrombus, drug or alcohol addiction, or unwillingness or inability to complete study follow-up. 16.Severe renal impairment, defined as an estimated glomerular filtration rate of less than 30 mL/min/1.73 m²; 17.Previous catheter ablation for atrial fibrillation; 18.Primary severe sinus node dysfunction;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success rate from the end of the 3-month blanking period through 12 months after the procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in quality-of-life scores;Incidence of cardiovascular rehospitalization;Incidence of atrial arrhythmias during the 3-month blanking period;Time to first recurrence of atrial arrhythmia;Composite of periprocedural complications and serious adverse events within 30 days after the procedure;Proportion of participants undergoing repeat catheter ablation; | — |
Countries
China
Contacts
Public ContactLiqun Wu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed