Comparison of Circumferential Pulmonary Vein Isolation and Complex Pulmonary Vein Isolation Additional Linear Ablation for Recurred Atrial Fibrillation After Previous Catheter Ablation: Prospective Randomized Trial (RILI Trial)

Not Applicable

Completed

• Conditions: Recurred Atrial Fibrillation
• Interventions: Procedure: Procedure with circumferential pulmonary vein isolation; Procedure: Procedure with linear ablation in addiction to pulmonary vein isolation

• Registration Number: NCT02747498
• Lead Sponsor: Yonsei University

Brief Summary

The purpose of this study is to compare the clinical outcomes depending on catheter ablation strategy for repeat ablation procedure among the patients with recurred atrial fibrillation after de novo catheter ablation. After randomization, we will conduct circumferential pulmonary vein isolation alone in a group, and additional posterior box isolation in the other group. Non-pulmonary vein foci ablation will be done in all patients. We will compare clinical recurrence rate, complication rate, and procedure time, etc.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-21
• Primary Completion: 2020-09-16
• Study Completion: 2020-09-16
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-25
• Last Update Posted: 2022-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Patients with AF aged between 20 and 80 years old.
2. Patients possible to anticoagulation and anti arrhythmic drug
3. Patients who had undergone de novo ablation procedures based on circumferential pulmonary vein isolation with no additional linear ablations
4. Patients undergoing a second ablation procedure due to clinical recurrence resistant to antiarrhythmic drugs with findings of PV reconnections

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Exclusion Criteria

1. Structural cardiac disease 2. Contraindication to brain perfusion CT 3. Catheter ablation history for AF, Cardiac surgery for AF 4. active internal bleeding 5. Impossible to anticoagulation or antiarrhythmic drug 6. valvular AF ((MA> GII, Mechanical valve, Mitral valve raplacement) 7. Patients with severe medical disease 8. Expected survival < 1year 9. Severe alcoholics, drug addiction 10. Pregnancy 11. LA diameter>60mm

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
circumferential pulmonary vein isolation	Procedure with circumferential pulmonary vein isolation	Procedure with circumferential pulmonary vein isolation for atrial fibrillation
Posterior box isolation in addiction to pulmonary vein isolation	Procedure with linear ablation in addiction to pulmonary vein isolation	Posterior box isolation in addiction to circumferential pulmonary vein isolation

Primary Outcome Measures

Name	Time	Method
Clinical recurrence of atrial fibrillation after catheter ablation	3 years	We defined recurrence of AF as any episode of AF or atrial tachycardia lasting longer than 30 sec. Any ECG documentation of AF recurrence after 3 months was diagnosed as clinical recurrence.

Secondary Outcome Measures

Name	Time	Method
procedure time	1 day
rate of hospitalization	3 years
procedure related complication rate	3 years

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of