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)

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

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.

Study Overview

• Status: Completed
• Conditions: Recurred Atrial Fibrillation
• Intervention / Treatment: Procedure: Procedure with circumferential pulmonary vein isolation; Procedure: Procedure with linear ablation in addiction to pulmonary vein isolation

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: circumferential pulmonary vein isolation; Procedure with circumferential pulmonary vein isolation for atrial fibrillation	Procedure: Procedure with circumferential pulmonary vein isolation; We will compare circumferential pulmonary vein (PV) isolation (CPVI) alone and posterior box isolation in addition to CPVI in patients with AF recurrence after de novo ablation procedures and with PV reconnections with 1:1 randomization. We will conduct ablation procedures by 3D electroanatomical mapping guidance and confirm bidirectional blocks of each ablation lines by differential pacing. For posterior box isolation, we will ablate remaining atrial potentials with point by point ablation to avoid the risk of esophageal injury at posterior inferior line. In all patients, mapping and ablation for non-pulmonary vein foci will be done with isoproterenol infusion at the end of the procedure. We will compare procedure time, ablation time, procedure related complication rates, and clinical recurrence rate of AF during follow-up period.
EXPERIMENTAL: Posterior box isolation in addiction to pulmonary vein isolation; Posterior box isolation in addiction to circumferential pulmonary vein isolation	Procedure: Procedure with linear ablation in addiction to pulmonary vein isolation; We will compare circumferential pulmonary vein (PV) isolation (CPVI) alone and posterior box isolation in addition to CPVI in patients with AF recurrence after de novo ablation procedures and with PV reconnections with 1:1 randomization. We will conduct ablation procedures by 3D electroanatomical mapping guidance and confirm bidirectional blocks of each ablation lines by differential pacing. For posterior box isolation, we will ablate remaining atrial potentials with point by point ablation to avoid the risk of esophageal injury at posterior inferior line. In all patients, mapping and ablation for non-pulmonary vein foci will be done with isoproterenol infusion at the end of the procedure. We will compare procedure time, ablation time, procedure related complication rates, and clinical recurrence rate of AF during follow-up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical recurrence of atrial fibrillation after catheter ablation	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.	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
procedure time	1 day
procedure related complication rate	3 years
rate of hospitalization	3 years

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Kim D, Yu HT, Kim TH, Uhm JS, Joung B, Lee MH, Pak HN. Electrical Posterior Box Isolation in Repeat Ablation for Atrial Fibrillation: A Prospective Randomized Clinical Study. JACC Clin Electrophysiol. 2022 May;8(5):582-592. doi: 10.1016/j.jacep.2022.01.003. Epub 2022 Feb 23.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): September 16, 2020
• Study Completion (ACTUAL): September 16, 2020

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (ESTIMATE): April 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: posterior wall isolation; CPVI; Recurred atrial fibullation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: 4-2015-1057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO