Systematic Evaluation of Ablation Techniques for Non-Paroxysmal Atrial Fibrillation.

STATUS

Recruiting
End date

Jun 28, 2027
participants needed

932
sponsor

Montefiore Medical Center

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Updated on 19 February 2024

See if I qualify

dyspnea

atrial fibrillation

chest pain

ablation techniques

catheter ablation

left ventricular dysfunction

fibrillation

pulmonary vein isolation

paroxysmal atrial fibrillation

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.

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.

Details

Condition	Arrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation
Age	18years - 99years
Treatment	Catheter ablation
Clinical Study Identifier	NCT04216667
Sponsor	Montefiore Medical Center
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Provision of signed and dated informed consent form
	Stated willingness to comply with all study procedures and availability for the duration of the study
	Male or female, aged 18 or greater
	In good general health as evidenced by medical history and diagnosed with symptomatic persistent AF or long-standing persistent AF
	Persistent AF will be defined as a sustained episode lasting > 7 days and less than 1 year
	Long-standing persistent AF will be defined as a sustained episode lasting more than 1 year and less than 10 years
	Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above
	At least one episode of persistent AF must have been documented by ECG, Holter, loop recorder, ziopatch, telemetry, trans telephonic monitoring (TTM), or implantable device within last 10 years of enrollment in this investigation
	Patients undergoing first time procedure for AF
Exclusion Criteria
	Patients with paroxysmal AF
	Paroxysmal AF will be defined as a sustained episode lasting < 7 days (either
	terminated spontaneously or with pharmacological or electrical cardioversion
	\. Reversible causes of AF
	\. Patients with contraindications to systemic anticoagulation with heparin
	or coumadin, direct thrombin inhibitor or factor Xa inhibitors
	\. Patients with left atrial size 75 mm (2D echocardiography, parasternal
	long axis view)
	\. Left atrial or LAA thrombus
	\. Patients with severe valvular heart disease or after mitral valve
	replacement (bioprosthetic or mechanical)
	\. Patients with a life expectancy 24 months
	\. CHA2DS2Vasc score of 0 for men and CHA2DS2Vasc score of 1 for women
	\. Patients who are pregnant

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Systematic Evaluation of Ablation Techniques for Non-Paroxysmal Atrial Fibrillation.