Atrial Fibrillation (AF)
Conditions
Keywords
persistent atrial fibrillation, pulsed field ablation, EI-VOM
Brief summary
Atrial fibrillation (AF) is one of the most common clinical arrhythmias, and catheter ablation serves as a critical therapeutic approach. For persistent atrial fibrillation, several proposed ablation strategies-including the 2C3L technique, BOX lesion sets, and substrate modification-remain highly controversial regarding long-term success rates. Multiple studies suggest that linear ablation beyond pulmonary vein isolation (PVI) often fails to achieve durable block due to incomplete ablation lines, which significantly contributes to postoperative recurrence of atrial arrhythmias. In recent years, electrophysiologists have explored various methods to improve mitral isthmus (MI) ablation, such as combined endo-epicardial ablation and radiofrequency ablation (RFA) combined with Marshall vein alcohol ablation. While RFA combined with anhydrous alcohol injection into the Marshall vein enhances MI block rates, it is associated with prolonged procedure time, unpredictable ablation zones, and higher complication risks (e.g., coronary artery spasm, pericarditis). Pulsed field ablation (PFA), an emerging non-thermal ablation technology, offers potential advantages such as tissue selectivity, shorter procedure time, and fewer complications. Studies report that RFA achieves near 100% immediate block rates; however, there is a lack of sufficient comparative studies on the efficacy and safety between these two ablation approaches. This study aims to compare the clinical outcomes and safety profiles of PFA versus RFA combined with Marshall vein alcohol injection in patients with persistent AF.
Interventions
PROCEDUREcatheter ablation
In the experimental group, patients receive pulsed field ablation (PFA) to achieve pulmonary vein isolation (PVI), circumferential BOX ablation around bilateral pulmonary veins, and mitral isthmus ablation. In the control group, anhydrous alcohol is first injected into the Marshall vein, followed by radiofrequency catheter ablation to complete PVI, BOX lesion sets, and mitral isthmus ablation.
Sponsors
lingzhiyu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Persistent atrial fibrillation; 2. Ejection fraction \>30%; 3. NYHA functional class I-III; 4. Left atrial diameter \<55 mm on echocardiography; 5. Signed informed consent form;
Exclusion criteria
1. Pregnant or lactating women; 2. Patients with a life expectancy of less than 2 years due to non-cardiovascular factors; 3. Uncontrolled hyperthyroidism, severe liver or kidney dysfunction; 4. History of atrial fibrillation ablation; 5. History of heart transplantation, complex congenital heart disease, or rheumatic heart disease; 6. Contraindications to contrast agents, radiofrequency ablation, antiarrhythmic drugs, or anticoagulants; 7. Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular 8.accident within 12 weeks prior to enrollment; 9.Other conditions deemed unsuitable for participation by investigators; 10.Participation in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate success rate of mitral isthmus ablation block | immediately after the procedure | Bidirectional MI block was confirmed by the following criteria: (1) proximal-to-distal CS activation pattern when pacing at the left lateral ridge; (2) longer SA interval at the left lateral ridge when pacing at the distal CS compared to pacing at the proximal CS |
| Mitral isthmus block rate | 20 minutes after the procedure | Bidirectional MI block was confirmed by the following criteria: (1) proximal-to-distal CS activation pattern when pacing at the left lateral ridge; (2) longer SA interval at the left lateral ridge when pacing at the distal CS compared to pacing at the proximal CS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of atrial arrhythmias (tachycardia, atrial flutter, atrial fibrillation) over 30 seconds without antiarrhythmic drugs was followed up for 12 months. | 1 year | The incidence of atrial arrhythmias (tachycardia, atrial flutter, atrial fibrillation) over 30 seconds without antiarrhythmic drugs was followed up for 12 months. |
| time of operation | immediately after the procedure | Total operating time,Ablation time,Mitral isthmus ablation time,Radiation time; |
| complication | 2 weeks after the procedure | Incidence of pericardial tamponade, acute heart failure, pericardial effusion, pleural effusion; Puncture complications; Incidence of cerebral infarction and TIA; Death; |
Contacts
Primary ContactZhiyu Ling, PhD
Outcome results
None listed