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Systematic Evaluation of Ablation Techniques for Non-Paroxysmal Atrial Fibrillation. (PLEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216667
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Jorge Romero, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Catheter ablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 932 participants
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.
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.
Primary Purpose: Treatment
Official Title: Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation (The PLEA Trial)
Actual Study Start Date : January 16, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2027

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)


  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. All-cause mortality [ Time Frame: 12, 24 and 60 months ]
    Death from all causes will be assessed

  4. Atrial contractility [ Time Frame: 6 months ]
    Myocardial strain will be used to assess atrial contractility after catheter ablation

  5. Heart failure analysis [ Time Frame: 12, 24 and 60 months ]
    Primary outcome will be assessed base on left ventricular ejection fraction (LVEF)

  6. 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.

  7. Procedure duration and fluoroscopy time [ Time Frame: Day of Procedure ]
    These times will be compared amongst groups

  8. Number of repeat procedures [ Time Frame: 12 months ]
    Number of repeat procedures within 12 months after the first ablation procedure

  9. 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.

  10. 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)


  11. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216667


Contacts
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Contact: Nadia Persaud, RN 718-920-8576 Napersaud@montefiore.org
Contact: Isabella Alviz, MD 8609948176 ialvizgome@Montefiore.org

Locations
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United States, Florida
Miami Cardiac & Vascular Institute Not yet recruiting
Miami, Florida, United States, 33176
Contact: Juan Viles-Gonzalez, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: David Briceno, MD         
United States, Texas
Texas Cardiac Arrhythmia Institute Not yet recruiting
Austin, Texas, United States, 78705
Contact: Andrea Natale, MD         
Colombia
University CES Not yet recruiting
Medellín, Antioquia, Colombia
Contact: Juan Carlos Diaz, MD         
Sponsors and Collaborators
Montefiore Medical Center
Biosense Webster, Inc.
Investigators
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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:
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.
Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: Executive summary. Europace. 2018 Jan 1;20(1):157-208. doi: 10.1093/europace/eux275. Review.

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Responsible Party: Jorge Romero, Co-Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT04216667    
Other Study ID Numbers: 2019-10714
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jorge Romero, Montefiore Medical Center:
Catheter Ablation
Arrhythmia Recurrence
Embolic Stroke
Mortality
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes