NCT04216667

Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation

Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation (The PLEA Trial)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of empirical posterior wall isolation (PWI), left atrial appendage electrical isolation (LAAEI) and coronary sinus isolation (CSI) when compared to pulmonary vein isolation (PVI) alone: * PVI alone, * PVI + PWI, * PVI + PWI + LAAEI, * PVI + PWI + LAAEI + CSI.

Detailed description

The Posterior Wall and/or Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation (The PLEA Trial) is a prospective multicenter randomized controlled study that has the overall goal of establishing the efficacy and safety of different ablation techniques for patients with persistent and long-standing persistent atrial fibrillation. The PLEA trial is designed to test the hypothesis whether posterior wall isolation (PWI) with pulmonary vein isolation (PVI), PWI plus left atrial appendage electrical isolation (LAAEI) with PVI and PWI plus LAAEI plus coronary sinus isolation (CSI) with PVI is superior to the standard approach alone (i.e. PVI alone) in decreasing the incidence of the composite endpoint of all-cause mortality and all-atrial arrhythmia recurrences.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Catheter ablation	Catheter ablation

Timeline

• Start date: 2020-01-16
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2020-01-03
• Last updated: 2023-08-31

Locations

16 sites across 7 countries: United States, Argentina, Brazil, Colombia, Germany, Portugal, Turkey (Türkiye)