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

Montefiore Medical Center124 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

124

Conditions

Atrial Fibrillation

Interventions

Catheter ablationPROCEDURE

Catheter ablation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 or greater 4. In good general health as evidenced by medical history and diagnosed with symptomatic persistent AF or long-standing persistent AF. 1. Persistent AF will be defined as a sustained episode lasting \> 7 days and less than 1 year. 2. Long-standing persistent AF will be defined as a sustained episode lasting more than 1 year and less than 10 years. 3. 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. 5. 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. 6. Patients undergoing first time procedure for AF. Exclusion Criteria: 1. 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. 2. Reversible causes of AF. 3. Patients with contraindications to systemic anticoagulation with heparin or coumadin, direct thrombin inhibitor or factor Xa inhibitors. 4. Patients with left atrial size ≥ 75 mm (2D echocardiography, parasternal long axis view) 5. Left atrial or LAA thrombus 6. Patients with severe valvular heart disease or after mitral valve replacement (bioprosthetic or mechanical). 7. Patients with a life expectancy ≤ 24 months 8. CHA2DS2Vasc score of 0 for men and CHA2DS2Vasc score of 1 for women. 9. Patients who are pregnant.

Locations (16)

Grandview Medical Center

Birmingham, Alabama, United States

MarinHealth Medical Center

Larkspur, California, United States

University of Colorado

Outcomes

Primary Outcomes

Freedom from documented AF/AT/AFL episodes and all-cause mortality after initial procedure

The primary effectiveness endpoint is defined as the freedom from documented AF/AT/AFL episodes (\> 30 seconds) and all-cause mortality within 12 months after one ablation procedure without antiarrhythmic medications after blanking period (3 months after ablation) as adjudicated by the independent Core Laboratory. Atrial Fibrillation (AF) Atrial Tachycardia (AT) Atrial Flutter (AFL)

Time frame: 12 months

A composite of thromboembolic events, myocardial perforation, pulmonary vein stenosis, atrioesophageal fistula, left and right phrenic nerve paralysis, and other serious adverse events within 12 months post-procedure.

The primary safety endpoint is defined as a composite of thromboembolic events, myocardial perforation, pulmonary vein stenosis, atrioesophageal fistula, left and right phrenic nerve paralysis, and other serious adverse events within 12 months post-procedure.

Time frame: 12 months

Secondary Outcomes

Incidence of peri-procedural and 12-month post procedural complications.

These complications include: ischemic stroke, pulmonary veins (PVs) stenosis, cardiac perforation, esophageal injury, phrenic nerve paralysis, rehospitalization, and death.

Time frame: 12, 24 and 60 months

AF/AT/AFL Burden

Atrial fibrillation (AF), atrial tachycardia (AT) and/or atrial flutter (AFL) burden at 12 months after single and redo procedures

Time frame: 12, 24 and 60 months

All-cause mortality

Death from all causes will be assessed

Time frame: 12, 24 and 60 months

Atrial contractility

Data from ClinicalTrials.gov

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