Addition of Six Short Lines on Pulmonary Vein Isolation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Addition of Six Short Ablation Lines on Pulmonary Vein Isolation Circumferences Reduces Recurrence Rate of Paroxysmal Atrial Fibrillation

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Procedure: PVI
* Procedure: CPVI+6L


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients between the ages of 18 and 80 years undergoing their first ablation of atrial fibrillation. 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. Resistant or intolerant to at least one class I, II, or III antiarrhythmic drugs. Patients deemed candidates for radiofrequency ablation of atrial fibrillation. Able and willing to comply with pre-, post-, and follow-up requirements. Exclusion criteria Left atrial thrombus by pre-procedural imaging. Uncontrolled heart failure: New York Heart Association Class III or IV, or left ventricular ejection fraction< 40% Myocardial infarction, unstable angina, coronary stenting within the previous 90 days. Stroke or any thrombo-embolic events within the previous 90 days. Expecting cardiac transplantation or other cardiac surgery within 180 days. History of catheter ablation of atrial fibrillation, atrial flutter or atrial tachycardia. History of blood clotting or bleeding abnormalities. Contraindication to anticoagulation. History of cardiac surgery. Uncontrolled maligment tumor. Patients in dialysis or creatinine > 221 μmol/L. Patients with alanine aminotransferase > 150 U/L or aspartate aminotransferase > 76 U/L Acute illness or active infection at time of index procedure or leukocytosis for which antibiotics have been or will be prescribed. Life expectancy less than 1 year. Women who are pregnant or who plan to become pregnant during the study. Other significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVI<br>Pulmonary vein isolation (PVI) | Procedure: PVI<br>* Pulmonary vein isolation<br>|
| Experimental: PVI+6L<br>PVI plus 6 additional lines at 1, 3 and 6 o'clock (from internal view) of left PV and 6, 9 and 11 o'clock of right PV | Procedure: CPVI+6L<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from AF recurrence between 91 and 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. | 91 to 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF burden | Percentage of time in AF, atrial flutter or atrial tachycardia on 14-days continuous monitoring at 12 months. | 12 months | 
| Procedural time | Total procedural time from femoral vein puncture to decannulation (skin-to-skin time) | Within procedure | 
| Fluoroscopy time | Time of patients' exposure to the real-time X-ray imaging during the procedure. | Within procedure | 
| Ablation time | Radiofrequency delivery time during the procedure. | Within procedure | 
| Early onset complications | 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. | Within 30 days | 
| Late onset complications | Complications detected any time during the follow-up, including severe pulmonary vein stenosis (>70%), and atrioesophageal fistula. | within 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paroxysmal Atrial Fibrillation; Ablation