Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.
  5. Persistent AF will be defined as a sustained episode lasting > 7 days and less than 1 year.
  6. Long-standing persistent AF will be defined as a sustained episode lasting more than 1 year and less than 10 years.
  7. 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.
  8. 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.
  9. 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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes 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.

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
David Briceno, MD

More Details

Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

Nadia Persaud, RN
718-920-8576
Napersaud@montefiore.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.