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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Catheter ablation
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Catheter Ablation, Arrhythmia Recurrence, Embolic Stroke, Mortality

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Grandview Medical Center
  • MarinHealth Medical Center
  • University of Colorado
  • Miami Cardiac & Vascular Institute
  • Indiana University
  • Montefiore Medical Center
  • WakedMed Heart & Vascular
  • University of Pennsylvania
  • Texas Cardiac Arrhythmia Institute
  • Baylor Heart Clinic
  • Instituto Cardiovascular Adventista
  • Incor - HCFMUSP
  • University CES
  • Cardioangiologisches Centrum Bethanien
  • Hospital Santa Cruz
  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

PVI

PVI + PWI

PVI + PWI + LAAEI

PVI + PWI + LAAEI + CSI

Arm Description

Pulmonary vein isolation alone will be performed using radiofrequency energy

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

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

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

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

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.
AF/AT/AFL Burden
Atrial fibrillation (AF), atrial tachycardia (AT) and/or atrial flutter (AFL) burden at 12 months after single and redo procedures
All-cause mortality
Death from all causes will be assessed
Atrial contractility
Myocardial strain will be used to assess atrial contractility after catheter ablation
Heart failure analysis
Primary outcome will be assessed base on left ventricular ejection fraction (LVEF)
Cardiovascular hospitalizations
Cardiovascular hospitalization was characterized by the site principal investigator (PI) and reported as part of the hospitalization case report form.
Procedure duration and fluoroscopy time
These times will be compared amongst groups
Number of repeat procedures
Number of repeat procedures within 12 months after the first ablation procedure
Cost-effectiveness analysis
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.
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
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)
Freedom from documented AF/AT/AFL episodes (>30 seconds) and all-cause mortality within 12 months after redo ablation procedure.
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.

Full Information

First Posted
December 31, 2019
Last Updated
August 29, 2023
Sponsor
Montefiore Medical Center
Collaborators
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04216667
Brief Title
Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation
Acronym
PLEA
Official Title
Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation (The PLEA Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
Collaborators
Biosense Webster, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Catheter Ablation, Arrhythmia Recurrence, Embolic Stroke, Mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of 932 patients will be randomized with equal allocation to one of four treatment groups. This sample size provides 90% power to detect pairwise differences in response rates between groups ranging from 0.12 to 0.15 based on two-tailed 0.05 level intention to treat chi-squared tests. Specifically, the response rates under the alternative upon which sample size is determined are 0.45, 0.60, 0.75, 0.87 for PVI alone, PVI + PWI, PVI + PWI + LAAEI and PVI + PWI + LAAEI + CSI respectively.
Masking
ParticipantOutcomes Assessor
Masking Description
The nature of the ablation procedures precludes blinding of physicians to patient treatment. However, patients will be blinded to their ablation strategy (single-blind design) and endpoint assessment will be made by blinded adjudicators from an independent core laboratory.
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PVI
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation alone will be performed using radiofrequency energy
Arm Title
PVI + PWI
Arm Type
Experimental
Arm Description
Pulmonary vein isolation plus posterior wall isolation will be performed using radiofrequency energy
Arm Title
PVI + PWI + LAAEI
Arm Type
Experimental
Arm Description
Pulmonary vein isolation plus posterior wall isolation plus left atrial appendage electrical isolation will be performed using radiofrequency energy
Arm Title
PVI + PWI + LAAEI + CSI
Arm Type
Experimental
Arm Description
Pulmonary vein isolation plus posterior wall isolation plus left atrial appendage electrical isolation plus coronary sinus isolation will be performed using radiofrequency energy
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation
Intervention Description
Catheter ablation
Primary Outcome Measure Information:
Title
Freedom from documented AF/AT/AFL episodes and all-cause mortality after initial procedure
Description
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
Title
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.
Description
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 Outcome Measure Information:
Title
Incidence of peri-procedural and 12-month post procedural complications.
Description
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
Title
AF/AT/AFL Burden
Description
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
Title
All-cause mortality
Description
Death from all causes will be assessed
Time Frame
12, 24 and 60 months
Title
Atrial contractility
Description
Myocardial strain will be used to assess atrial contractility after catheter ablation
Time Frame
6 months
Title
Heart failure analysis
Description
Primary outcome will be assessed base on left ventricular ejection fraction (LVEF)
Time Frame
12, 24 and 60 months
Title
Cardiovascular hospitalizations
Description
Cardiovascular hospitalization was characterized by the site principal investigator (PI) and reported as part of the hospitalization case report form.
Time Frame
12, 24 and 60 months
Title
Procedure duration and fluoroscopy time
Description
These times will be compared amongst groups
Time Frame
Day of Procedure
Title
Number of repeat procedures
Description
Number of repeat procedures within 12 months after the first ablation procedure
Time Frame
12 months
Title
Cost-effectiveness analysis
Description
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.
Time Frame
12 months
Title
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
Description
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)
Time Frame
24 and 60 months
Title
Freedom from documented AF/AT/AFL episodes (>30 seconds) and all-cause mortality within 12 months after redo ablation procedure.
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge E Romero, MD
Organizational Affiliation
Montefiore Medical Center/Albert Einstein College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luigi Di Biase, MD, PhD
Organizational Affiliation
Montefiore Medical Center/Albert Einstein College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Institute and St. David's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grandview Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
MarinHealth Medical Center
City
Larkspur
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
University of Colorado
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States
Facility Name
Miami Cardiac & Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
WakedMed Heart & Vascular
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Cardiac Arrhythmia Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor Heart Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Instituto Cardiovascular Adventista
City
Buenos Aires
Country
Argentina
Facility Name
Incor - HCFMUSP
City
Sao Paulo
Country
Brazil
Facility Name
University CES
City
Medellín
State/Province
Antioquia
Country
Colombia
Facility Name
Cardioangiologisches Centrum Bethanien
City
Frankfurt
Country
Germany
Facility Name
Hospital Santa Cruz
City
Lisbon
Country
Portugal
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
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Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation

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