NCT04405258

Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial

Randomized Clinical Trial of Additional Left Atrial Posterior Wall Isolation for Persistent Atrial Fibrillation

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Institute for Clinical Effectiveness, Japan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Atrial Fibrillation
• Catheter Ablation
• Pulmonary Vein Isolation
• Posterior Wall Isolation

Interventions

Type	Name	Description
PROCEDURE	Pulmonary vein isolation	Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation
PROCEDURE	Left posterior wall isolation	Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation

Timeline

• Start date: 2020-06-08
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2020-05-28
• Last updated: 2024-06-14

Locations

1 site across 1 country: Japan