None listed
Conditions
Interventions
Others(left bundle branch area pacing, LBBAP + AVJ ablation) : 1. All study participants will undergo pulmonary vein isolation (PVI) according to a standardized protocol using the Varipulse™ system.
2
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 years and older with paroxysmal atrial fibrillation (AF). 2. Patients scheduled for their first pulmonary vein isolation (PVI) using the Varipulse™ pulsed-field ablation system. 3. Stroke low-risk patients with a CHA2DS2-VA score of 0 or 1. 4. Patients who have been on anticoagulation therapy for at least 3 weeks prior to the procedure. 5. Patients who fully understand the study objectives, procedure, and anticoagulation strategies, and have provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Persistent or long-standing persistent atrial fibrillation. 2. CHA2DS2-VA score = 2. 3. History of prior left atrial ablation, pulmonary vein isolation, or other heart surgery. 4. Contraindication to anticoagulant use or patients at high risk of severe bleeding. 5. History of ischemic stroke, transient ischemic attack (TIA), or systemic embolism within the past 30 days. 6. Active bleeding or uncontrolled bleeding disorders. 7. Malignant tumors, severe liver disease, renal failure, or patients with an expected survival of less than one year. 8. Pregnant or breastfeeding women. 9. Patients for whom follow-up in accordance with the study protocol is deemed difficult. 10. Other patients deemed unsuitable for participation in the clinical trial at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of composite events occurring within 3 months after the procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the incidence rates of individual events such as thromboembolism and bleeding;Comparison of adherence to anticoagulant therapy.;Cost-effectiveness analysis;Comparison of patient-reported outcomes (PROs);Incidence rate of major cardiovascular events. | — |
Countries
Korea, Republic of
Contacts
Public ContactAnna Choi
Yonsei University Health System, Severance Hospital
Outcome results
None listed