Back to resultsComparison 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)
Primary Purpose
Recurred Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Procedure with circumferential pulmonary vein isolation
Procedure with linear ablation in addiction to pulmonary vein isolation
Sponsored by
About this trial
This is an interventional treatment trial for Recurred Atrial Fibrillation focused on measuring Recurred atrial fibullation, CPVI, posterior wall isolation
Eligibility Criteria
Inclusion Criteria:
- Patients with AF aged between 20 and 80 years old.
- Patients possible to anticoagulation and anti arrhythmic drug
- Patients who had undergone de novo ablation procedures based on circumferential pulmonary vein isolation with no additional linear ablations
- 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
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
circumferential pulmonary vein isolation
Posterior box isolation in addiction to pulmonary vein isolation
Arm Description
Procedure with circumferential pulmonary vein isolation for atrial fibrillation
Posterior box isolation in addiction to circumferential pulmonary vein isolation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
procedure time
procedure related complication rate
rate of hospitalization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02747498
Brief Title
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)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
September 16, 2020 (Actual)
Study Completion Date
September 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurred Atrial Fibrillation
Keywords
Recurred atrial fibullation, CPVI, posterior wall isolation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
circumferential pulmonary vein isolation
Arm Type
Active Comparator
Arm Description
Procedure with circumferential pulmonary vein isolation for atrial fibrillation
Arm Title
Posterior box isolation in addiction to pulmonary vein isolation
Arm Type
Experimental
Arm Description
Posterior box isolation in addiction to circumferential pulmonary vein isolation
Intervention Type
Procedure
Intervention Name(s)
Procedure with circumferential pulmonary vein isolation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Procedure with linear ablation in addiction to pulmonary vein isolation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical recurrence of atrial fibrillation after catheter ablation
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
procedure time
Time Frame
1 day
Title
procedure related complication rate
Time Frame
3 years
Title
rate of hospitalization
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with AF aged between 20 and 80 years old.
Patients possible to anticoagulation and anti arrhythmic drug
Patients who had undergone de novo ablation procedures based on circumferential pulmonary vein isolation with no additional linear ablations
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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35589170
Citation
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.
Results Reference
derived
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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)
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