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Insufficient enrollment
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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI | Active Comparator | Pulmonary vein isolation alone will be performed using radiofrequency energy |
|
| PVI + PWI | Experimental | Pulmonary vein isolation plus posterior wall isolation will be performed using radiofrequency energy |
|
| PVI + PWI + LAAEI | Experimental | Pulmonary vein isolation plus posterior wall isolation plus left atrial appendage electrical isolation will be performed using radiofrequency energy |
|
| PVI + PWI + LAAEI + CSI | Experimental | Pulmonary vein isolation plus posterior wall isolation plus left atrial appendage electrical isolation plus coronary sinus isolation will be performed using radiofrequency energy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation | Procedure | Catheter ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12, 24 and 60 months |
| AF/AT/AFL Burden |
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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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grandview Medical Center | Birmingham | Alabama | 35243 | United States | ||
| MarinHealth Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29342299 | Background | Romero J, Michaud GF, Avendano R, Briceno DF, Kumar S, Carlos Diaz J, Mohanty S, Trivedi C, Gianni C, Della Rocca D, Proietti R, Perrotta L, Bordignon S, Chun JKR, Schmidt B, Garcia M, Natale A, Di Biase L. Benefit of left atrial appendage electrical isolation for persistent and long-standing persistent atrial fibrillation: a systematic review and meta-analysis. Europace. 2018 Aug 1;20(8):1268-1278. doi: 10.1093/europace/eux372. | |
| 28122885 |
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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.
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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.
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 | Death from all causes will be assessed | 12, 24 and 60 months |
| Atrial contractility | Myocardial strain will be used to assess atrial contractility after catheter ablation | 6 months |
| Heart failure analysis | Primary outcome will be assessed base on left ventricular ejection fraction (LVEF) | 12, 24 and 60 months |
| Cardiovascular hospitalizations | 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 | These times will be compared amongst groups | Day of Procedure |
| Number of repeat procedures | Number of repeat procedures within 12 months after the first ablation procedure | 12 months |
| 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. | 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 | 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. | 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 |
| Larkspur |
| California |
| 94904 |
| United States |
| University of Colorado | Boulder | Colorado | 80309 | United States |
| Miami Cardiac & Vascular Institute | Miami | Florida | 33176 | United States |
| Indiana University | Bloomington | Indiana | 47405 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| WakedMed Heart & Vascular | Raleigh | North Carolina | 27610 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Cardiac Arrhythmia Institute | Austin | Texas | 78705 | United States |
| Baylor Heart Clinic | Houston | Texas | 77030 | United States |
| Instituto Cardiovascular Adventista | Buenos Aires | Argentina |
| Incor - HCFMUSP | São Paulo | Brazil |
| University CES | MedellÃn | Antioquia | Colombia |
| Cardioangiologisches Centrum Bethanien | Frankfurt | Germany |
| Hospital Santa Cruz | Lisbon | Portugal |
| Hacettepe University | Ankara | Turkey (Türkiye) |
| Background |
| Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez 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. No abstract available. |
| 24345399 | Background | Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17. |
| 29016841 | Background | 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. No abstract available. |
| 27788847 | Background | Di Biase L, Burkhardt JD, Mohanty P, Mohanty S, Sanchez JE, Trivedi C, Gunes M, Gokoglan Y, Gianni C, Horton RP, Themistoclakis S, Gallinghouse GJ, Bailey S, Zagrodzky JD, Hongo RH, Beheiry S, Santangeli P, Casella M, Dello Russo A, Al-Ahmad A, Hranitzky P, Lakkireddy D, Tondo C, Natale A. Left Atrial Appendage Isolation in Patients With Longstanding Persistent AF Undergoing Catheter Ablation: BELIEF Trial. J Am Coll Cardiol. 2016 Nov 1;68(18):1929-1940. doi: 10.1016/j.jacc.2016.07.770. |
| 3210508 | Background | Ludka L. [Fasting during childbirth]. Katilolehti. 1988 Sep;93(6):25-8. No abstract available. Finnish. |
| 20719881 | Background | Allessie MA, de Groot NM, Houben RP, Schotten U, Boersma E, Smeets JL, Crijns HJ. Electropathological substrate of long-standing persistent atrial fibrillation in patients with structural heart disease: longitudinal dissociation. Circ Arrhythm Electrophysiol. 2010 Dec;3(6):606-15. doi: 10.1161/CIRCEP.109.910125. Epub 2010 Aug 18. |
| 20206320 | Background | Brooks AG, Stiles MK, Laborderie J, Lau DH, Kuklik P, Shipp NJ, Hsu LF, Sanders P. Outcomes of long-standing persistent atrial fibrillation ablation: a systematic review. Heart Rhythm. 2010 Jun;7(6):835-46. doi: 10.1016/j.hrthm.2010.01.017. Epub 2010 Jan 22. |
| 27042964 | Background | Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4. |
| 25946280 | Background | Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288. |
| 28279292 | Background | Lim HS, Hocini M, Dubois R, Denis A, Derval N, Zellerhoff S, Yamashita S, Berte B, Mahida S, Komatsu Y, Daly M, Jesel L, Pomier C, Meillet V, Amraoui S, Shah AJ, Cochet H, Sacher F, Jais P, Haissaguerre M. Complexity and Distribution of Drivers in Relation to Duration of Persistent Atrial Fibrillation. J Am Coll Cardiol. 2017 Mar 14;69(10):1257-1269. doi: 10.1016/j.jacc.2017.01.014. |
| 26277862 | Background | Bai R, Di Biase L, Mohanty P, Trivedi C, Dello Russo A, Themistoclakis S, Casella M, Santarelli P, Fassini G, Santangeli P, Mohanty S, Rossillo A, Pelargonio G, Horton R, Sanchez J, Gallinghouse J, Burkhardt JD, Ma CS, Tondo C, Natale A. Proven isolation of the pulmonary vein antrum with or without left atrial posterior wall isolation in patients with persistent atrial fibrillation. Heart Rhythm. 2016 Jan;13(1):132-40. doi: 10.1016/j.hrthm.2015.08.019. Epub 2015 Aug 13. |
| 19808442 | Background | Tamborero D, Mont L, Berruezo A, Matiello M, Benito B, Sitges M, Vidal B, de Caralt TM, Perea RJ, Vatasescu R, Brugada J. Left atrial posterior wall isolation does not improve the outcome of circumferential pulmonary vein ablation for atrial fibrillation: a prospective randomized study. Circ Arrhythm Electrophysiol. 2009 Feb;2(1):35-40. doi: 10.1161/CIRCEP.108.797944. Epub 2008 Dec 3. |
| 22972873 | Background | Lim TW, Koay CH, See VA, McCall R, Chik W, Zecchin R, Byth K, Seow SC, Thomas L, Ross DL, Thomas SP. Single-ring posterior left atrial (box) isolation results in a different mode of recurrence compared with wide antral pulmonary vein isolation on long-term follow-up: longer atrial fibrillation-free survival time but similar survival time free of any atrial arrhythmia. Circ Arrhythm Electrophysiol. 2012 Oct;5(5):968-77. doi: 10.1161/CIRCEP.111.970293. Epub 2012 Sep 12. |
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| 36640437 | Derived | Diaz JC, Canas F, Duque M, Aristizabal J, Nino C, Bastidas O, Marin J, Rivera E, Hoyos C, Matos C, Peralta A, Martin DT, Romero J. Assisted reality device to guide cardiac implantable device programming in distant rural areas. J Cardiovasc Electrophysiol. 2023 Mar;34(3):497-501. doi: 10.1111/jce.15815. Epub 2023 Jan 22. |
| 35333095 | Derived | Osorio J, Varley A, Kreidieh O, Godfrey B, Schrappe G, Rajendra A, Silverstein J, Romero J, Rodriguez D, Morales G, Zei P. High-Frequency, Low-Tidal-Volume Mechanical Ventilation Safely Improves Catheter Stability and Procedural Efficiency During Radiofrequency Ablation of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2022 Apr;15(4):e010722. doi: 10.1161/CIRCEP.121.010722. Epub 2022 Mar 25. No abstract available. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D000083262 | Embolic Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
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