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

August 29, 2023 updated by: Montefiore Medical Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Instituto Cardiovascular Adventista
  • Brazil
      • Sao Paulo, Brazil
        • Incor - HCFMUSP
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia
        • University CES
  • Germany
      • Frankfurt, Germany
        • Cardioangiologisches Centrum Bethanien
  • Portugal
      • Lisbon, Portugal
        • Hospital Santa Cruz
  • Turkey
      • Ankara, Turkey
        • Hacettepe University
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Grandview Medical Center
    • California
      • Larkspur, California, United States, 94904
        • MarinHealth Medical Center
    • Colorado
      • Boulder, Colorado, United States, 80309
        • University of Colorado
    • Florida
      • Miami, Florida, United States, 33176
        • Miami Cardiac & Vascular Institute
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Indiana University
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • WakedMed Heart & Vascular
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Institute
      • Houston, Texas, United States, 77030
        • Baylor Heart Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PVI
Pulmonary vein isolation alone will be performed using radiofrequency energy
Procedure: Catheter ablation
Catheter ablation
Experimental: PVI + PWI
Pulmonary vein isolation plus posterior wall isolation will be performed using radiofrequency energy
Procedure: Catheter ablation
Catheter ablation
Experimental: PVI + PWI + LAAEI
Pulmonary vein isolation plus posterior wall isolation plus left atrial appendage electrical isolation will be performed using radiofrequency energy
Procedure: Catheter ablation
Catheter ablation
Experimental: 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
Procedure: Catheter ablation
Catheter ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from documented AF/AT/AFL episodes and all-cause mortality after initial procedure
Time Frame: 12 months

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)
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.
Time Frame: 12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of peri-procedural and 12-month post procedural complications.
Time Frame: 12, 24 and 60 months
These complications include: ischemic stroke, pulmonary veins (PVs) stenosis, cardiac perforation, esophageal injury, phrenic nerve paralysis, rehospitalization, and death.
12, 24 and 60 months
AF/AT/AFL Burden
Time Frame: 12, 24 and 60 months
Atrial fibrillation (AF), atrial tachycardia (AT) and/or atrial flutter (AFL) burden at 12 months after single and redo procedures
12, 24 and 60 months
All-cause mortality
Time Frame: 12, 24 and 60 months
Death from all causes will be assessed
12, 24 and 60 months
Atrial contractility
Time Frame: 6 months
Myocardial strain will be used to assess atrial contractility after catheter ablation
6 months
Heart failure analysis
Time Frame: 12, 24 and 60 months
Primary outcome will be assessed base on left ventricular ejection fraction (LVEF)
12, 24 and 60 months
Cardiovascular hospitalizations
Time Frame: 12, 24 and 60 months
Cardiovascular hospitalization was characterized by the site principal investigator (PI) and reported as part of the hospitalization case report form.
12, 24 and 60 months
Procedure duration and fluoroscopy time
Time Frame: Day of Procedure
These times will be compared amongst groups
Day of Procedure
Number of repeat procedures
Time Frame: 12 months
Number of repeat procedures within 12 months after the first ablation procedure
12 months
Cost-effectiveness analysis
Time Frame: 12 months
The CEA will examine the cost of health care resources and health outcomes from the ablation procedure to 1-year postoperatively. The costs will include all health care utilization during this time. Health care utilization, and associated costs, related to the patients' condition, the procedure and adverse events will be the basis of a sensitivity analysis.
12 months
Long-term follow-up at 24 and 60 months to evaluate freedom of documented AF/AT/AFL episodes (>30 seconds) and all-cause mortality adjudicated by the Core Laboratory
Time Frame: 24 and 60 months

Freedom from documented AF/AT/AFL episodes (> 30 seconds) and all-cause mortality within 24 and 60 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)
24 and 60 months
Freedom from documented AF/AT/AFL episodes (>30 seconds) and all-cause mortality within 12 months after redo ablation procedure.
Time Frame: 12 months
Freedom from all-atrial arrhythmias recurrence (AF/atrial flutter [AFL]/atrial tachycardia [AT]) (episodes >30 seconds on 12-lead ECG, event monitor, Zio patch, Holter or device interrogation) and all-cause mortality (patients who die before the 12-month assessment or who are too ill to undergo assessment of AF are considered not to have response to treatment) during the evaluation period at 12 months after redo-ablation procedures as adjudicated by the independent Core Laboratory.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

Biosense Webster, Inc.

Investigators

  • Principal Investigator: Jorge E Romero, MD, Montefiore Medical Center/Albert Einstein College of Medicine
  • Principal Investigator: Luigi Di Biase, MD, PhD, Montefiore Medical Center/Albert Einstein College of Medicine
  • Principal Investigator: Andrea Natale, MD, Texas Cardiac Arrhythmia Institute and St. David's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

December 31, 2019

First Submitted That Met QC Criteria

December 31, 2019

First Posted (Actual)

January 3, 2020

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-10714

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Catheter ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe