Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial

Phase 4

Active, not recruiting

• Conditions: Persistent Atrial Fibrillation; Catheter Ablation; Posterior Wall Isolation; Pulmonary Vein Isolation
• Interventions: Procedure: Left posterior wall isolation; Procedure: Pulmonary vein isolation

• Registration Number: NCT04405258
• Lead Sponsor: Institute for Clinical Effectiveness, Japan

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-23
• Study First Posted: 2020-05-28
• Study Start: 2020-06-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 276

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI and PWI	Left posterior wall isolation	Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation
PVI alone	Pulmonary vein isolation	Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation

Primary Outcome Measures

Name	Time	Method
Recurrence of atrial tachyarrhythmia after 90-day blanking period of catheter ablation	18 months	Recurrence of atrial tachyarrhythmia is defined atrial arrhythmia that needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.

Secondary Outcome Measures

Name	Time	Method
Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of catheter ablation	18 months	Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.
Recurrence of atrial fibrillation or atrial tachycardia within 90-day after catheter ablation	90 days	Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.
Atrial Fibrillation Quality of Life Questionnaire	18 months	Atrial Fibrillation Quality of Life Questionnaire
Repeated ablation of atrial tachyarrhythmia	18 months
Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of repeated ablation	18 months
Complications of ablation procedure	1 month	Complications of ablation procedure includes death, cardiac tamponade, pericardial effusion, systemic embolism, symptomatic strokes, hematoma, A-V shunt, pericarditis, phrenic nerve paralysis, A-V block, procedure-related infections, heart failure, atrio-esophageal fistula, esophageal vagus nerve injury

Trial Locations

Locations (1)

Kagawa Prefectural Central Hospital; 🇯🇵 Takamatsu, Kagawa, Japan