Paroxysmal atrial fibrillation
Conditions
Interventions
Nanosecond pulsed field ablation group:Nanosecond pulsed field ablation
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) 18 years of age =75 years of age 2) The clinical diagnosis was paroxysmal atrial fibrillation 3) The disease recurred and the symptoms were obvious before enrollment 4) Atrial fibrillation was recorded by body surface electrocardiogram or by dynamic electrocardiogram (including single-lead electrocardiograph) for =30 s within 1 year before admission; 5) Ineffective or intolerance after treatment with at least one Class I or III antiarrhythmic drug 6) Fully understand the treatment plan, and voluntarily sign informed consent, willing to carry out the examination, surgery and follow-up required by the plan.
Exclusion criteria
Exclusion criteria: 1) Patients who had undergone surgery for atrial fibrillation 2) Left atrial thrombus 3) Patients of childbearing age who could not take effective contraceptive measures during the 12 months after enrollment 4) Anterior and posterior diameter of left atrium =50mm 5) Left ventricular ejection fraction (LVEF) =40% 6) Atrial fibrillation caused by hyperthyroidism or non-cardiac causes 7) Past atrial septal repair or atrial myxoma 8) Carry active implants (such as pacemakers, ICDs, etc.) 9) NYHA Grade ?-? cardiac function 10) Patients with definite cerebrovascular diseases within the last 6 months (including cerebral hemorrhage, stroke, and short stroke) Transient ischemic attack) 11) Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventricular otomy) 12) Acute or severe systemic infection 13) Patients with severe liver and kidney diseases, malignant tumors and end-stage diseases, which researchers believe may interfere with the treatment, evaluation and compliance of this trial 14) Patients with obvious bleeding tendency, hypercoagulability and serious blood system diseases 15) Patients who had participated or were participating in other clinical trials within the 3 months prior to enrollment 16) Patients with other conditions deemed inappropriate by the investigator to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success rate within 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of immediate ablation;Pulse catheter evaluation;Pulse equipment evaluation;Primary safety endpoint;The incidence of adverse events caused by study device;The incidence of serious adverse events caused by study device; | — |
Countries
China
Contacts
Public ContactZeng Rui
West China Hospital, Sichuan University
Outcome results
None listed