Clinical trial NCT02637453: Addition of Six Short Lines on Pulmonary Vein Isolation
Official title: Addition of Six Short Ablation Lines on Pulmonary Vein Isolation Circumferences Reduces Recurrence Rate of Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Paroxysmal Atrial Fibrillation; Ablation
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Xuzhou Central Hospital
name: Shanghai East Hospital
name: Shanghai Chest Hospital
First posted: 2015-12-22
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Freedom from AF recurrence between 91 and 365 days
timeFrame: 91 to 365 days
Secondary outcomes:
measure: AF burden
timeFrame: 12 months
measure: Procedural time
timeFrame: Within procedure
measure: Fluoroscopy time
timeFrame: Within procedure
measure: Ablation time
timeFrame: Within procedure
measure: Early onset complications
timeFrame: Within 30 days
measure: Late onset complications
timeFrame: within 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicne
state: Shanghai
Study officials:
affiliation: Department of Cardiology, Xinhua Hospital, Shanghai Jiaotong University School of Medicne
name: Yi-Gang Li, MD.
role: PRINCIPAL_INVESTIGATOR
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