Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation
NCT ID: NCT07021313
Last Updated: 2025-07-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
378 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-06-20
Study Completion Date
2028-06-30
Brief Summary
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Pulmonary vein isolation (PVI) by catheter ablation (CA) has become a widely accepted interventional treatment for patients with symptomatic atrial fibrillation (AF) despite anti-arrhythmic drugs (AAD). Classic thermal ablation modalities use radiofrequency energy or cryo-energy to create cardiac tissue lesions. Irreversible electroporation (IRE) using pulsed field energy (PFA) is a novel technology for cardiac tissue ablation. Initial studies have shown favorable outcome data in patients with AF treated by performing PVI using PFA. However, the freedom of AF has not yet proven superior to existing thermal ablation methods and appears similarly associated with suboptimal lesion durability, leading to electrical reconnection. The purpose of this study is to determine if freedom of atrial fibrillation may be improved by delivering more and better targeted pulsed field ablations.
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Detailed Description
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Pulmonary vein isolation (PVI) by catheter ablation (CA) has become a widely accepted interventional treatment for patients with symptomatic atrial fibrillation (AF) despite anti-arrhythmic drugs (AAD). Classic thermal ablation modalities use radiofrequency energy or cryo-energy to create cardiac tissue lesions. Irreversible electroporation (IRE) using pulsed field energy (PFA) is a novel technology for cardiac tissue ablation. Initial studies have shown favorable outcome data in patients with AF treated by performing PVI using PFA. However, the freedom of AF has not yet proven superior to existing thermal ablation methods and appears similarly associated with suboptimal lesion durability, leading to electrical reconnection. The purpose of this study is to determine if freedom of atrial fibrillation may be improved by delivering more and better targeted pulsed field ablations. Patients will undergo the standard catheter ablation procedure in accordance with good clinical practice, performing pulmonary vein islolation (PVI) with the FARAPULSE cardiac ablation system. In the control group PVI will be performed with 4 basket- and 4 flower-shaped applications of the catheter, while in the study group 2 olive-, 4 basket-, and 6 flower shaped applications will be delivered at each vein. All other procedural steps will be the same between groups. Patients will be randomized in a 1:1 fashion with a block size of 4 to the study arm or the usual care (control) arm. The primary study parameter for efficacy is the freedom of atrial arrhythmias after the 2-month blanking period up to 12 months after the procedure. The secondary study outcomes include the extent and position of pulmonary vein reconnection observed during redo procedures that are performed due to arrhythmia recurrence, which constitutes a study endpoint. Furthermore, the study also evaluates arrhythmia burden after the procedure in centers that routinely use photoplethysmographic remote monitoring as standard care for all their ablation patients.
Conditions
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Atrial Fibrillation
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Patients will be randomized in a 1:1 fashion with a block size of 4 to the study arm or the usual care (control) arm.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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Experimental arm, extra applications
Pulmonary vein isolation will be performed with the pentaspline ablation catheter in an olive-shape (2x), basket shape (4x), and flower shape (6x) at each vein
Group Type
EXPERIMENTAL
Pulmonary vein isolation by percutaneous endocardial catheter ablation using the FARAPULSE pulsed high voltage electrical field system in patients with atrial fibrillation
Intervention Type
DEVICE
Standard of care 4 pulsed electrical field applications in basket shape and 4 applications in flower shape
Control arm, standard of care
Pulmonary vein isolation will be performed with the pentaspline catheter in basket shape (4x) and flower shaped (4x) applications of the catheter.
Group Type
ACTIVE_COMPARATOR
Pulmonary vein isolation by percutaneous endocardial catheter ablation using a pentaspline pulsed high voltage electrical field system in patients with atrial fibrillation
Intervention Type
DEVICE
Experimental treatment delivering 2 pulsed electrical field applications in olive shape, 4 in basket shape and 6 applications in flower shape
Interventions
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Pulmonary vein isolation by percutaneous endocardial catheter ablation using the FARAPULSE pulsed high voltage electrical field system in patients with atrial fibrillation
Standard of care 4 pulsed electrical field applications in basket shape and 4 applications in flower shape
Intervention Type
DEVICE
Pulmonary vein isolation by percutaneous endocardial catheter ablation using a pentaspline pulsed high voltage electrical field system in patients with atrial fibrillation
Experimental treatment delivering 2 pulsed electrical field applications in olive shape, 4 in basket shape and 6 applications in flower shape
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Be scheduled for PVI with the use of the FARAPULSE catheter ablation system AND
* Have paroxysmal atrial fibrillation (PAF) documented in the last 6 months prior to enrolment OR
* Had persistent atrial fibrillation but maintained in SR or converted to paroxysmal by antiarrhythmic drugs with no more than 1 cardioversion beyond 7 days in the past
* Have paroxysmal atrial fibrillation (PAF) documented in the last 6 months prior to enrolment OR
* Had persistent atrial fibrillation but maintained in SR or converted to paroxysmal by antiarrhythmic drugs with no more than 1 cardioversion beyond 7 days in the past
Exclusion Criteria
* Cerebrovascular accident (CVA) in the last 6 months
* More than moderate valvular disease that would require intervention
* Cardiac catheter/surgical intervention in the last 3 months or scheduled
* Atrial septal defect (ASD)/ patent foramen ovale (PFO) closure in the past
* Left atrial appendage (LAA) closure in the past
* Mechanical mitral valve
* Non-adherence to oral anticoagulation in the 3 weeks prior to ablation
* Renal disease with known eGFR\<45 ml
* Left atrial volume index (LAVI) \>50 ml/m2 or left atrial diameter (LAD) \>50 mm
* Known contra-indication for catheter ablation
* Known contra-indication for deep sedation or general anesthesia
* Known pregnancy
* More than moderate valvular disease that would require intervention
* Cardiac catheter/surgical intervention in the last 3 months or scheduled
* Atrial septal defect (ASD)/ patent foramen ovale (PFO) closure in the past
* Left atrial appendage (LAA) closure in the past
* Mechanical mitral valve
* Non-adherence to oral anticoagulation in the 3 weeks prior to ablation
* Renal disease with known eGFR\<45 ml
* Left atrial volume index (LAVI) \>50 ml/m2 or left atrial diameter (LAD) \>50 mm
* Known contra-indication for catheter ablation
* Known contra-indication for deep sedation or general anesthesia
* Known pregnancy
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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R&D Cardiologie
OTHER
Sponsor Role
lead
Responsible Party
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L.V.A. Boersma
Clinical professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Lucas VA Boersma, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Antonius Hospital
Locations
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St. Antonius Hospital
Nieuwegein, , Netherlands
Site Status
RECRUITING
Countries
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Netherlands
Central Contacts
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Facility Contacts
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References
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Boersma L, Andrade JG, Betts T, Duytschaever M, Purerfellner H, Santoro F, Tzeis S, Verma A. Progress in atrial fibrillation ablation during 25 years of Europace journal. Europace. 2023 Aug 2;25(9):euad244. doi: 10.1093/europace/euad244.
Reference Type
BACKGROUND
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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, Cosedis Nielsen J, Curtis AB, Davies DW, Day JD, d'Avila A, Natasja de Groot NMS, 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; Document Reviewers:. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Europace. 2018 Jan 1;20(1):e1-e160. doi: 10.1093/europace/eux274. No abstract available.
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BACKGROUND
Koruth J, Verma A, Kawamura I, Reinders D, Andrade JG, Deyell MW, Mehta N, Reddy VY. PV Isolation Using a Spherical Array PFA Catheter: Preclinical Assessment and Comparison to Radiofrequency Ablation. JACC Clin Electrophysiol. 2023 May;9(5):652-666. doi: 10.1016/j.jacep.2023.01.022. Epub 2023 Feb 3.
Reference Type
BACKGROUND
Futing A, Reinsch N, Howel D, Brokkaar L, Rahe G, Neven K. First experience with pulsed field ablation as routine treatment for paroxysmal atrial fibrillation. Europace. 2022 Jul 21;24(7):1084-1092. doi: 10.1093/europace/euac041.
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BACKGROUND
Verma A, Asivatham SJ, Deneke T, Castellvi Q, Neal RE 2nd. Primer on Pulsed Electrical Field Ablation: Understanding the Benefits and Limitations. Circ Arrhythm Electrophysiol. 2021 Sep;14(9):e010086. doi: 10.1161/CIRCEP.121.010086. Epub 2021 Sep 20.
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BACKGROUND
Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11.
Reference Type
BACKGROUND
Hartl S, Reinsch N, Futing A, Neven K. Pearls and Pitfalls of Pulsed Field Ablation. Korean Circ J. 2023 May;53(5):273-293. doi: 10.4070/kcj.2023.0023.
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BACKGROUND
Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.
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BACKGROUND
Reddy VY, Gerstenfeld EP, Natale A, Whang W, Cuoco FA, Patel C, Mountantonakis SE, Gibson DN, Harding JD, Ellis CR, Ellenbogen KA, DeLurgio DB, Osorio J, Achyutha AB, Schneider CW, Mugglin AS, Albrecht EM, Stein KM, Lehmann JW, Mansour M; ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023 Nov 2;389(18):1660-1671. doi: 10.1056/NEJMoa2307291. Epub 2023 Aug 27.
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BACKGROUND
Schmidt B, Bordignon S, Neven K, Reichlin T, Blaauw Y, Hansen J, Adelino R, Ouss A, Futing A, Roten L, Mulder BA, Ruwald MH, Mene R, van der Voort P, Reinsch N, Kueffer T, Boveda S, Albrecht EM, Schneider CW, Chun KRJ. EUropean real-world outcomes with Pulsed field ablatiOn in patients with symptomatic atRIAl fibrillation: lessons from the multi-centre EU-PORIA registry. Europace. 2023 Jul 4;25(7):euad185. doi: 10.1093/europace/euad185.
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Verma A, Haines DE, Boersma LV, Sood N, Natale A, Marchlinski FE, Calkins H, Sanders P, Packer DL, Kuck KH, Hindricks G, Onal B, Cerkvenik J, Tada H, DeLurgio DB; PULSED AF Investigators. Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial. Circulation. 2023 May 9;147(19):1422-1432. doi: 10.1161/CIRCULATIONAHA.123.063988. Epub 2023 Mar 6.
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Tohoku S, Chun KRJ, Bordignon S, Chen S, Schaack D, Urbanek L, Ebrahimi R, Hirokami J, Bologna F, Schmidt B. Findings from repeat ablation using high-density mapping after pulmonary vein isolation with pulsed field ablation. Europace. 2023 Feb 16;25(2):433-440. doi: 10.1093/europace/euac211.
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Nakatani Y, Sridi-Cheniti S, Cheniti G, Ramirez FD, Goujeau C, Andre C, Nakashima T, Eggert C, Schneider C, Viswanathan R, Krisai P, Takagi T, Kamakura T, Vlachos K, Derval N, Duchateau J, Pambrun T, Chauvel R, Reddy VY, Montaudon M, Laurent F, Sacher F, Hocini M, Haissaguerre M, Jais P, Cochet H. Pulsed field ablation prevents chronic atrial fibrotic changes and restrictive mechanics after catheter ablation for atrial fibrillation. Europace. 2021 Nov 8;23(11):1767-1776. doi: 10.1093/europace/euab155.
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Musikantow DR, Neuzil P, Petru J, Koruth JS, Kralovec S, Miller MA, Funasako M, Chovanec M, Turagam MK, Whang W, Sediva L, Dukkipati SR, Reddy VY. Pulsed Field Ablation to Treat Atrial Fibrillation: Autonomic Nervous System Effects. JACC Clin Electrophysiol. 2023 Apr;9(4):481-493. doi: 10.1016/j.jacep.2022.10.028. Epub 2022 Nov 30.
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Bohnen M, Weber R, Minners J, Jadidi A, Eichenlaub M, Neumann FJ, Arentz T, Lehrmann H. Characterization of circumferential antral pulmonary vein isolation areas resulting from pulsed-field catheter ablation. Europace. 2023 Feb 8;25(1):65-73. doi: 10.1093/europace/euac111.
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Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.
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Patel C, Gerstenfeld EP, Gupta SK, Winterfield J, Woods C, Natale A, Schneider CW, Achyutha AB, Holland SK, Richards E, Albrecht EM, Lehmann JW, Mansour M, Reddy VY. Comparison of cerebral safety after atrial fibrillation using pulsed field and thermal ablation: Results of the neurological assessment subgroup in the ADVENT trial. Heart Rhythm. 2024 Nov;21(11):2103-2109. doi: 10.1016/j.hrthm.2024.05.048. Epub 2024 May 31.
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BACKGROUND
Mansour M, Gerstenfeld EP, Patel C, Natale A, Whang W, Cuoco FA, Mountantonakis SE, Gibson DN, Harding JD, Holland SK, Achyutha AB, Schneider CW, Mugglin AS, Albrecht EM, Stein KM, Lehmann JW, Reddy VY. Pulmonary vein narrowing after pulsed field versus thermal ablation. Europace. 2024 Feb 1;26(2):euae038. doi: 10.1093/europace/euae038.
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BACKGROUND
Reddy VY, Anic A, Koruth J, Petru J, Funasako M, Minami K, Breskovic T, Sikiric I, Dukkipati SR, Kawamura I, Neuzil P. Pulsed Field Ablation in Patients With Persistent Atrial Fibrillation. J Am Coll Cardiol. 2020 Sep 1;76(9):1068-1080. doi: 10.1016/j.jacc.2020.07.007.
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du Pre BC, van Driel VJ, van Wessel H, Loh P, Doevendans PA, Goldschmeding R, Wittkampf FH, Vink A. Minimal coronary artery damage by myocardial electroporation ablation. Europace. 2013 Jan;15(1):144-9. doi: 10.1093/europace/eus171. Epub 2012 May 31.
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Moshkovits Y, Grynberg D, Heller E, Maizels L, Maor E. Differential effect of high-frequency electroporation on myocardium vs. non-myocardial tissues. Europace. 2023 Feb 16;25(2):748-755. doi: 10.1093/europace/euac191.
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Reference Type
BACKGROUND
Other Identifiers
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NL88354.100.24
Identifier Type: -
Identifier Source: org_study_id
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