Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    268
  • sponsor
    Institute for Clinical Effectiveness, Japan
Updated on 19 February 2024
atrial fibrillation
persistent atrial fibrillation
catheter ablation
fibrillation
antiarrhythmic drug
pulmonary vein isolation
conversion to sinus rhythm
cardiac ablation

Summary

The purpose for this study is to determine whether left posterior wall isolation (PWI) in addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent atrial fibrillation (AF).

Description

PVI is cornerstone of AF ablation. However, clinical outcome of only PVI in patients with persistent AF is insufficient due to AF substrate extending to left atrium. Strategy of catheter ablation for persistent AF is not established despite attempts of numerous left atrial substrate modifications. Additional PWI on PVI is one of expected effective strategies for persistent AF, because PW originated from common tissue of PV and is considered to play a part in AF trigger and maintenance. However, this strategy is also not established in the recent international consensus statement. Following two reasons are considered. One is the procedural difficulty in creating durable PWI, and another is the existence of patients who can recover by only PVI. The latest technology, ablation index, can create durable PVI, and may create durable PWI. Several reports suggested that PVI only strategy was sufficient in the patients with persistent AF who could maintain sinus rhythm after pharmacological or electrical cardioversion. Therefore, we planed this randomized clinical trial that compared between PVI alone and additional PWI on PVI using ablation index in the patients with persistent AF without pharmacological sinus rhythm conversion.

Details
Condition Cardiac ablation, Arrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation, atrial fibrillation (pediatric), atrial fibrillation (pediatric), Pulmonary Vein Isolation, Posterior Wall Isolation
Age 18years - 100years
Treatment Pulmonary Vein Isolation, Left posterior wall isolation
Clinical Study IdentifierNCT04405258
SponsorInstitute for Clinical Effectiveness, Japan
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients scheduled for first catheter ablation of persistent atrial fibrillation
Patients without conversion to sinus rhythm within 30 days after antiarrhythmic drug administration
Patients with persisting duration of atrial fibrillation less than 3 years
Patients with left atrial diameter less than 50mm
Patients who can be followed up for 18 months
Patients with written informed consent

Exclusion Criteria

Patients who can not be received adequate anticoagulation therapy
Patients with history of myocardial infarction within 6 months
Patients with history of open heart surgery
Patients scheduled for open heart surgery
Patients with severe valvular heart disease
Patients during pregnancy
Patients with expected life expectancy less than 1 year due to malignancy or non-cardiovascular disease
Patients considered unsuitable for study by the attending physician
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