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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)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02747498
Enrollment
120
Registered
2016-04-21
Start date
2016-01-01
Completion date
2020-09-16
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurred Atrial Fibrillation

Keywords

Recurred atrial fibullation, CPVI, posterior wall isolation

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.

Interventions

PROCEDUREProcedure 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.

PROCEDUREProcedure 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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical recurrence of atrial fibrillation after catheter ablation3 yearsWe 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

MeasureTime frame
procedure time1 day
procedure related complication rate3 years
rate of hospitalization3 years

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026