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

  • STATUS
    Recruiting
  • End date
    Jun 2, 2027
  • participants needed
    932
  • sponsor
    Montefiore Medical Center
Updated on 4 October 2022
electrocardiogram
fibrillation
left ventricular dysfunction
catheter ablation
paroxysmal atrial fibrillation
pulmonary vein isolation

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 Atrial Fibrillation
Treatment catheter ablation
Clinical Study IdentifierNCT04216667
SponsorMontefiore Medical Center
Last Modified on4 October 2022

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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