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CompletedNCT02747498Updated Mar 14, 2022

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)

An interventional study of Procedure with circumferential pulmonary vein isolation and Procedure with linear ablation in addiction to pulmonary vein isolation in Recurred Atrial Fibrillation, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-14.

Sponsored by Yonsei University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2016, registered Apr 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Recurred Atrial Fibrillation

Keywords

  • Recurred atrial fibullation
  • CPVI
  • posterior wall isolation
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 120 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    circumferential pulmonary vein isolation

    Procedure with circumferential pulmonary vein isolation for atrial fibrillation

    Procedure: Procedure with circumferential pulmonary vein isolation

  • 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

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

Secondary outcomes

  1. procedure time

    Time frame: 1 day

  2. procedure related complication rate

    Time frame: 3 years

  3. rate of hospitalization

    Time frame: 3 years

07

Study locations

1 site
  • Severance Hospital
    Seoul, 120-752, Korea, Republic of
08

References and documents

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. PubMed 35589170 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02747498
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Apr 21, 2016
Start date
Jan 1, 2016
Primary completion
Sep 16, 2020
Completion
Sep 16, 2020
Last update
Mar 14, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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