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

NCT ID: NCT04216667

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-16
• Study Completion Date: 2023-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PVI

Pulmonary vein isolation alone will be performed using radiofrequency energy

Group Type: ACTIVE_COMPARATOR

Catheter ablation

Intervention Type: PROCEDURE

Catheter ablation

PVI + PWI

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

Group Type: EXPERIMENTAL

Catheter ablation

Intervention Type: PROCEDURE

Catheter ablation

PVI + PWI + LAAEI

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

Group Type: EXPERIMENTAL

Catheter ablation

Intervention Type: PROCEDURE

Catheter ablation

PVI + PWI + LAAEI + CSI

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

Group Type: EXPERIMENTAL

Catheter ablation

Intervention Type: PROCEDURE

Catheter ablation

Interventions

Catheter ablation

Catheter ablation

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge E Romero, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center/Albert Einstein College of Medicine

Luigi Di Biase, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center/Albert Einstein College of Medicine

Andrea Natale, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia Institute and St. David's Medical Center

Locations

Grandview Medical Center

Birmingham, Alabama, United States

MarinHealth Medical Center

Larkspur, California, United States

University of Colorado

Boulder, Colorado, United States

Miami Cardiac & Vascular Institute

Miami, Florida, United States

Indiana University

Bloomington, Indiana, United States

Montefiore Medical Center

The Bronx, New York, United States

WakedMed Heart & Vascular

Raleigh, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Texas Cardiac Arrhythmia Institute

Austin, Texas, United States

Baylor Heart Clinic

Houston, Texas, United States

Instituto Cardiovascular Adventista

Buenos Aires, , Argentina

Incor - HCFMUSP

São Paulo, , Brazil

University CES

Medellín, Antioquia, Colombia

Cardioangiologisches Centrum Bethanien

Frankfurt, , Germany

Hospital Santa Cruz

Lisbon, , Portugal

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

United States; Argentina; Brazil; Colombia; Germany; Portugal; Turkey (Türkiye)

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Other Identifiers

2019-10714

Identifier Type: -

Identifier Source: org_study_id