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

Montefiore Medicine Academic Health System

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Procedure: Catheter ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04216667

2019-10714

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 4 patient groups

PVI

Active Comparator group

Description:

Pulmonary vein isolation alone will be performed using radiofrequency energy

Treatment:

Procedure: Catheter ablation

PVI + PWI

Experimental group

Description:

Pulmonary vein isolation plus posterior wall isolation will be performed using radiofrequency energy

Treatment:

Procedure: Catheter ablation

PVI + PWI + LAAEI

Experimental group

Description:

Pulmonary vein isolation plus posterior wall isolation plus left atrial appendage electrical isolation will be performed using radiofrequency energy

Treatment:

Procedure: Catheter ablation

PVI + PWI + LAAEI + CSI

Experimental group

Description:

Pulmonary vein isolation plus posterior wall isolation plus left atrial appendage electrical isolation plus coronary sinus isolation will be performed using radiofrequency energy

Treatment:

Procedure: Catheter ablation