PLAI-AF Trial: Hybrid Endo-epicardial Partial Left Atrial Isolation vs. Endocardial Ablation in Patients With Persistent Atrial Fibrillation
NCT ID: NCT05723536
Last Updated: 2023-02-24
Study Results
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Basic Information
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RECRUITING
PHASE3
80 participants
INTERVENTIONAL
2023-04-01
2025-12-31
Brief Summary
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While percutaneous ablation has good results in patients with paroxysmal AF, it is not clear which is the best technique in patients with persistent or long-standing persistent AF. Our group performed the first randomized study of thoracoscopic epicardial ablation vs. endocardial catheter ablation (FAST Trial), which showed better results for epicardial ablation but with a higher rate of complications. Hybrid epicardial and endocardial ablation strategies have recently been described sequentially, showing better results in patients with persistent AF, but 40% of patients are still refractory to ablation.
Our study aims to compare the conventional strategy (catheter ablation) with partial electrical isolation of the left atrium endo-epicardially (pulmonary veins, posterior wall and left atrial appendage) in a single procedure in the group of patients most refractory to ablation. Likewise, using magnetic resonance imaging and echocardiography to analyze the atrial remodeling factors that can predict the success and failure of both therapies.
Methodology: A 1:1 randomized clinical trial in patients with persistent and long-standing persistent AF in two groups: conventional ablation vs. partial endo-epicardial isolation. Prior to ablation, cardioversion will be performed and functionality and atrial size will be verified by echocardiography and delayed-enhancement magnetic resonance imaging (MRI) will detect the degree of fibrosis and atrial remodeling. During the ablation procedure, a continuous rhythm recording device will be implanted. Likewise, at three months the MRI will be repeated to detect post-ablation fibrosis. At six months the echocardiography will be performed to assess atrial function and size.
Main Expected Results: The expected results include: 1. an improvement in the rate of patients with no atrial arrhythmias recurrence in patients undergoing endo-epicardial ablation; 2. a lower AF burden in patients undergoing endo-epicardial ablation who have had recurrence; 3. To know the degree of atrial fibrosis associated with the success/failure of each technique; 4. To know the degree of fibrosis that both techniques produce; 5. To know the degree of ventricular function associated with the success/failure of each technique; 6. To know the degree of potentially lost atrial function; 7. To Compare the safety of both techniques
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PLAI (Partial Left Atrial Isolation)
Partial electrical isolation of the left atrium endo-epicardially (pulmonary veins, posterior wall and left atrial appendage) and left atrial appendage isolation using Atriclip (Atricure, Mason OH, USA) in a single procedure in patients with persistent atrial fibrillation.
Partial Left Atrial Isolation
Partial electrical isolation of the left atrium endo-epicardially (pulmonary veins, posterior wall and left atrial appendage) and left atrial appendage isolation using Atriclip (Atricure, Mason OH, USA) in a single procedure in patients with persistent atrial fibrillation.
CA (Catheter Ablation)
Conventional catheter ablation of persistent atrial fibrillation.
Catheter Ablation
Catheter Ablation of Atrial Fibrillation
Interventions
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Partial Left Atrial Isolation
Partial electrical isolation of the left atrium endo-epicardially (pulmonary veins, posterior wall and left atrial appendage) and left atrial appendage isolation using Atriclip (Atricure, Mason OH, USA) in a single procedure in patients with persistent atrial fibrillation.
Catheter Ablation
Catheter Ablation of Atrial Fibrillation
Eligibility Criteria
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Inclusion Criteria
2. Patients with persistent atrial fibrillation refractory to at least one antiarrhythmic drug (Class I or III).
3. Signature of written informed consent.
Exclusion Criteria
2. Moderate to severe valvular heart disease.
3. Severe atrial dilatation (left appendage AP diameter \> 55 mm or \> 50ml/m2).
4. Patients requiring concomitant cardiac surgery or with previous cardiac surgery.
5. Left ventricular ejection fraction \<40%.
6. History of pericarditis.
7. Previous stroke.
8. Presence of active infection or sepsis, esophageal ulcer stricture and/or esophageal varices.
9. Patients with renal dysfunction defined as GFR less than or equal to 40 ml/min/m2.
10. Contraindication for chronic anticoagulation.
11. Patients who have undergone prior left atrial catheter ablation for atrial fibrillation or who are receiving treatment for ventricular arrhythmia.
12. Patients with severe chronic obstructive pulmonary disease considered GOLD III.
13. Patients with active neoproliferative disease or other concomitant disease where the medical team considers that ablation places the patient at unacceptable risk.
14. Pregnant, lactating women.
15. Patients who have previously presented allergic reactions to gadolinium.
16. Patients with claustrophobia that makes it impossible to perform nuclear magnetic resonance.
18 Years
75 Years
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Locations
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Hospital Clínic de Barcelona
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Castella M, Kotecha D, van Laar C, Wintgens L, Castillo Y, Kelder J, Aragon D, Nunez M, Sandoval E, Casellas A, Mont L, van Boven WJ, Boersma LVA, van Putte BP. Thoracoscopic vs. catheter ablation for atrial fibrillation: long-term follow-up of the FAST randomized trial. Europace. 2019 May 1;21(5):746-753. doi: 10.1093/europace/euy325.
Boersma LV, Castella M, van Boven W, Berruezo A, Yilmaz A, Nadal M, Sandoval E, Calvo N, Brugada J, Kelder J, Wijffels M, Mont L. Atrial fibrillation catheter ablation versus surgical ablation treatment (FAST): a 2-center randomized clinical trial. Circulation. 2012 Jan 3;125(1):23-30. doi: 10.1161/CIRCULATIONAHA.111.074047. Epub 2011 Nov 14.
Maesen B, Pison L, Vroomen M, Luermans JG, Vernooy K, Maessen JG, Crijns HJ, La Meir M. Three-year follow-up of hybrid ablation for atrial fibrillation. Eur J Cardiothorac Surg. 2018 Apr 1;53(suppl_1):i26-i32. doi: 10.1093/ejcts/ezy117.
DeLurgio DB, Crossen KJ, Gill J, Blauth C, Oza SR, Magnano AR, Mostovych MA, Halkos ME, Tschopp DR, Kerendi F, Taigen TL, Shults CC, Shah MH, Rajendra AB, Osorio J, Silver JS, Hook BG, Gilligan DM, Calkins H. Hybrid Convergent Procedure for the Treatment of Persistent and Long-Standing Persistent Atrial Fibrillation: Results of CONVERGE Clinical Trial. Circ Arrhythm Electrophysiol. 2020 Dec;13(12):e009288. doi: 10.1161/CIRCEP.120.009288. Epub 2020 Nov 13.
Yorgun H, Canpolat U, Kocyigit D, Coteli C, Evranos B, Aytemir K. Left atrial appendage isolation in addition to pulmonary vein isolation in persistent atrial fibrillation: one-year clinical outcome after cryoballoon-based ablation. Europace. 2017 May 1;19(5):758-768. doi: 10.1093/europace/eux005.
Whitlock RP, Belley-Cote EP, Paparella D, Healey JS, Brady K, Sharma M, Reents W, Budera P, Baddour AJ, Fila P, Devereaux PJ, Bogachev-Prokophiev A, Boening A, Teoh KHT, Tagarakis GI, Slaughter MS, Royse AG, McGuinness S, Alings M, Punjabi PP, Mazer CD, Folkeringa RJ, Colli A, Avezum A, Nakamya J, Balasubramanian K, Vincent J, Voisine P, Lamy A, Yusuf S, Connolly SJ; LAAOS III Investigators. Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke. N Engl J Med. 2021 Jun 3;384(22):2081-2091. doi: 10.1056/NEJMoa2101897. Epub 2021 May 15.
Bisbal F, Benito E, Teis A, Alarcon F, Sarrias A, Caixal G, Villuendas R, Garre P, Soto N, Cozzari J, Guasch E, Junca G, Prat-Gonzalez S, Perea RJ, Bazan V, Tolosana JM, Arbelo E, Bayes-Genis A, Mont L. Magnetic Resonance Imaging-Guided Fibrosis Ablation for the Treatment of Atrial Fibrillation: The ALICIA Trial. Circ Arrhythm Electrophysiol. 2020 Nov;13(11):e008707. doi: 10.1161/CIRCEP.120.008707. Epub 2020 Oct 8.
Bisbal F, Guiu E, Cabanas-Grandio P, Berruezo A, Prat-Gonzalez S, Vidal B, Garrido C, Andreu D, Fernandez-Armenta J, Tolosana JM, Arbelo E, de Caralt TM, Perea RJ, Brugada J, Mont L. CMR-guided approach to localize and ablate gaps in repeat AF ablation procedure. JACC Cardiovasc Imaging. 2014 Jul;7(7):653-63. doi: 10.1016/j.jcmg.2014.01.014. Epub 2014 May 7.
Althoff TF, Garre P, Caixal G, Perea R, Prat S, Tolosana JM, Guasch E, Roca-Luque I, Arbelo E, Sitges M, Brugada J, Mont L. Late gadolinium enhancement-MRI determines definite lesion formation most accurately at 3 months post ablation compared to later time points. Pacing Clin Electrophysiol. 2022 Jan;45(1):72-82. doi: 10.1111/pace.14415. Epub 2021 Dec 15.
Sanz-de la Garza M, Grazioli G, Bijnens BH, Sarvari SI, Guasch E, Pajuelo C, Brotons D, Subirats E, Brugada R, Roca E, Sitges M. Acute, Exercise Dose-Dependent Impairment in Atrial Performance During an Endurance Race: 2D Ultrasound Speckle-Tracking Strain Analysis. JACC Cardiovasc Imaging. 2016 Dec;9(12):1380-1388. doi: 10.1016/j.jcmg.2016.03.016. Epub 2016 Aug 17.
Gabrielli L, Herrera S, Contreras-Briceno F, Vega J, Ocaranza MP, Yanez F, Fernandez R, Saavedra R, Sitges M, Garcia L, Chiong M, Lavandero S, Castro PF. Increased active phase atrial contraction is related to marathon runner performance. Eur J Appl Physiol. 2018 Sep;118(9):1931-1939. doi: 10.1007/s00421-018-3927-7. Epub 2018 Jul 3.
Other Identifiers
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HCB/2022/1059
Identifier Type: -
Identifier Source: org_study_id
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