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Giant Left Atrium Atrial fibrillatioN CathEter Ablation, Posterior Box Isolation vs. Dallas Lesion Set

NCT04632550 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2020-11-17

No results posted yet for this study

Summary

Although the additional linear ablation after pulmonary vein isolation (PVI) is a class IIB indication for AF catheter ablation in patients with persistent AF, no clear benefit has been demonstrated in the recent randomized clinical trials (STAR-AF2 or POBI trials). Nevertheless, in the retrospective cohort data of this research team, additional POBI and AL were helpful in persistent AF patients with left atrial (LA) size \> 50mm or more or low LA voltage. The purpose of this study was to evaluate the efficacy and safety of additional POBI and AL compared to CPVI alone in persistent AF patients with LA size over 50mm. Also, we intend to proceed with this randomized clinical trial with the high power short duration ablation protocol, which is effective in shortening the procedure time.

Conditions

Interventions

PROCEDURE

Circumferential pulmonary vein isolation(CPVI) group

1. PVI(pulmonary vein isolation) will be performed using a radiofrequency catheter 2. Esophageal temperature will be monitored to prevent esophageal injury. 3. Evaluation of procedure time, radiofrequency ablation time 4. Evaluation of the complication after the procedure. 5. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

PROCEDURE

Posterior box isolation(POBI) group

1. PVI will be performed using a radiofrequency catheter 2. Additional POBI(Posterior box isolation) is performed according to the traditional method and experience of the practitioner. 3. Esophageal temperature will be monitored to prevent esophageal injury. 4. The bidirectional block of each lesion set is the target of the procedures. But, we remain the incomplete block if three times of linear ablation failed to achieve the bidirectional block for the safety purpose. 5. Evaluation of procedure time, radiofrequency ablation time 6. Evaluation of the complication after the procedure. 7. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

PROCEDURE

POBI+Anterior linear ablation(AL) group

1. PVI, POBI will be performed using a radiofrequency catheter 2. Additional AL(anterior linear) ablation is performed according to the traditional method and experience of the practitioner. 3. Esophageal temperature will be monitored to prevent esophageal injury. 4. The bidirectional block of each lesion set is the target of the procedures. But, we remain the incomplete block if three times of linear ablation failed to achieve the bidirectional block for the safety purpose. 5. Evaluation of procedure time, radiofrequency ablation time 6. Evaluation of the complication after the procedure. 7. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Hui-Nam Pak · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04632550 on ClinicalTrials.gov