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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Yonsei University

Status

Completed

Conditions

Recurred Atrial Fibrillation

Treatments

Procedure: Procedure with circumferential pulmonary vein isolation
Procedure: Procedure with linear ablation in addiction to pulmonary vein isolation

Study type

Interventional

Funder types

Other

Identifiers

NCT02747498
4-2015-1057

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

circumferential pulmonary vein isolation
Active Comparator group
Description:
Procedure with circumferential pulmonary vein isolation for atrial fibrillation
Treatment:
Procedure: Procedure with circumferential pulmonary vein isolation
Posterior box isolation in addiction to pulmonary vein isolation
Experimental group
Description:
Posterior box isolation in addiction to circumferential pulmonary vein isolation
Treatment:
Procedure: Procedure with linear ablation in addiction to pulmonary vein isolation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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