Addition of Six Short Lines on Pulmonary Vein Isolation

Not Applicable

Completed

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Procedure: CPVI+6L; Procedure: PVI

• Registration Number: NCT02637453
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-17
• Study First Posted: 2015-12-22
• Study Start: 2017-01-04
• Primary Completion: 2021-01-10
• Study Completion: 2021-01-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI+6L	CPVI+6L	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
PVI	PVI	Pulmonary vein isolation (PVI)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
AF burden	12 months	Percentage of time in AF, atrial flutter or atrial tachycardia on 14-days continuous monitoring at 12 months.
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.
Ablation time	Within procedure	Radiofrequency delivery time during the procedure.
Late onset complications	within 12 months	Complications detected any time during the follow-up, including severe pulmonary vein stenosis (\>70%), and atrioesophageal fistula.

Trial Locations

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicne; 🇨🇳 Shanghai, Shanghai, China