Long-term persistent atrial fibrillation
Conditions
Interventions
Control group:Pulmonary vein isolation (PVI)
Study Group 1:Pulmonary vein isolation (PVI) Low Voltage Zone (LVZ) High automatic peak frequency (PF) area ablation
Study Group 2:Pulmonary vein isolation (PVI) Linear ablation of high automatic peak frequency (PF) areas to adjacent anatomical barriers
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with non-valvular long-term persistent atrial fibrillation who have failed to respond to at least one anti-arrhythmic drug and undergo the first ablation. 2. Age 18-80 years old (including boundary values). 3. Voluntarily participate in this study, and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity or other reasons, his guardian needs to act as an agent for the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (e.g., illiterate subjects), a witness is required to witness the informed process and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Paroxysmal atrial fibrillation or persistent atrial fibrillation 5 years; 3. Patients with congenital or valvular heart disease. 4. Patients with systemic anticoagulation contraindications or left atrial appendage thrombosis; 5. Those who are pregnant or have a life expectancy of < 12 months. 6. Other conditions that the investigator considers unsuitable for participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Freedom from AF and/or ATs off-AADs (antiarrhythmic drugs) at 1 year after a single-ablation procedure. AF and/or AT occurring in the first 3 months after the ablation (blanking peri;Onset of atrial fibrillation/tachycardia lasts for > 30 seconds; | — |
Secondary
| Measure | Time frame |
|---|---|
| No recurrence (including blank period) at 1 year postoperatively;Re-ablation may require continuation of antiarrhythmic drug therapy;Surgery time, fluoroscopy time, ablation time, low voltage area area, high PF area and ablation extent;Perioperative complications (stroke, pulmonary vein stenosis, cardiac perforation, esophageal injury, death);Quality of life assessment; | — |
Countries
China
Contacts
Public ContactYu Lu
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed