Paroxysmal Atrial Fibrillation
Conditions
Keywords
Paroxysmal Atrial Fibrillation; Ablation
Brief summary
We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.
Detailed description
We randomly assigned 390 patients with symptomatic, paroxysmal AF to undergo catheter ablation with PVI (PVI group) alone or combined with 6 additional ablation lines extended outside the PVI circumferences at 1, 3 and 6 o'clock of left PV and 6, 9 and 11 o'clock of right PV (PVI+6L group). Patients received monthly 12-lead electrocardiogram, 24-hour Holter at 3, 6 and 9 months and 14-days continuous monitoring at 12 months to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was freedom from AF recurrence between 91 and 365 days after catheter ablation. The secondary end points included the AF burden, procedural parameters, and complications.
Interventions
PROCEDUREPVI
Pulmonary vein isolation
PROCEDURECPVI+6L
After PVI, 6 ablation lines were added with an extension from pulmonary vein ostium at 1, 3 and 6 o'clock (from internal view) of left PV and 6, 9 and 11 o'clock of right PV
Sponsors
Xuzhou Central Hospital
Shanghai East Hospital
Shanghai Chest Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients between the ages of 18 and 80 years undergoing their first ablation of atrial fibrillation. 2. Diagnosed with symptomatic paroxysmal atrial fibrillation, defined as an documented episode of atrial fibrillation that lasts more than 30 seconds and terminates in less than 7 days. 3. Resistant or intolerant to at least one class I, II, or III antiarrhythmic drugs. 4. Patients deemed candidates for radiofrequency ablation of atrial fibrillation. 5. Able and willing to comply with pre-, post-, and follow-up requirements.
Exclusion criteria
1. Left atrial thrombus by pre-procedural imaging. 2. Uncontrolled heart failure: New York Heart Association Class III or IV, or left ventricular ejection fraction\< 40% 3. Myocardial infarction, unstable angina, coronary stenting within the previous 90 days. 4. Stroke or any thrombo-embolic events within the previous 90 days. 5. Expecting cardiac transplantation or other cardiac surgery within 180 days. 6. History of catheter ablation of atrial fibrillation, atrial flutter or atrial tachycardia. 7. History of blood clotting or bleeding abnormalities. 8. Contraindication to anticoagulation. 9. History of cardiac surgery. 10. Uncontrolled maligment tumor. 11. Patients in dialysis or creatinine \> 221 μmol/L. 12. Patients with alanine aminotransferase \> 150 U/L or aspartate aminotransferase \> 76 U/L 13. Acute illness or active infection at time of index procedure or leukocytosis for which antibiotics have been or will be prescribed. 14. Life expectancy less than 1 year. 15. Women who are pregnant or who plan to become pregnant during the study. 16. Other significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from AF recurrence between 91 and 365 days | 91 to 365 days | AF recurrence was defined by AF (including atrial flutter or atrial tachycardia) of 30 seconds or more captured by ECG monitoring or any clinical presentation with AF outside the 90-day blanking period (between 91 and 365 days). Cardioversion, or use of class I or III antiarrhythmic drugs outside blanking period was also considered as AF recurrence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural time | Within procedure | Total procedural time from femoral vein puncture to decannulation (skin-to-skin time) |
| Fluoroscopy time | Within procedure | Time of patients' exposure to the real-time X-ray imaging during the procedure. |
| AF burden | 12 months | Percentage of time in AF, atrial flutter or atrial tachycardia on 14-days continuous monitoring at 12 months. |
| Early onset complications | Within 30 days | Complications within 30 days post-ablation, including death, myocardial infarction, diaphragmatic paralysis, stroke or transient ischemic attack, systemic embolism, pericardial effusion or tamponade requiring drainage, heart block, pericarditis, and vascular access complications requiring intervention. |
| Late onset complications | within 12 months | Complications detected any time during the follow-up, including severe pulmonary vein stenosis (\>70%), and atrioesophageal fistula. |
| Ablation time | Within procedure | Radiofrequency delivery time during the procedure. |
Countries
China
Outcome results
None listed