Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation

NCT07021313 | Recruiting FDA Device

• 1 other identifier: NL88354.100.24
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Pulsed Field Ablation; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Freedom of atrial fibrillation after a 2-month blanking period up to 12 months post procedure.

  The primary efficacy outcome will be the freedom of arrhythmias lasting \>30 seconds after a single PVI ablation procedure from the blanking period of 2 months until 12 months follow-up after ablation. The use of class I or III antiarrhythmic drugs should be stopped at the 3-month visit at the end of the blanking period, or else will count as treatment failure. Any left-sided ablation procedure after a successful index procedure will count as treatment failure. An atrioventricular (nodal) reentry tachycardia (AVNRT/AVRT), or typical right atrial flutter occurring after the index procedure, will not count as treatment failure.

  Baseline, month 3, month 6, month 12.

Secondary Outcomes (4)

• Procedural-up-to-30 days and 30 days up-to 12 months safety of increasing PFA application numbers

  From procedure to 12-month follow-up

• Quality of life differences between groups

  Baseline, month 3, month 6, month 12.

• The potential for hemolysis in relation to application number

  Post procedure every 24 hours, up to 5 days post procedure for each individual patient

• The durability of pulmonary vein isolation in case of a redo procedure

  Month 3, month 6, month 12.

Study Arms (2)

Experimental arm, extra applications

EXPERIMENTAL

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

Device: Pulmonary vein isolation by percutaneous endocardial catheter ablation using the FARAPULSE pulsed high voltage electrical field system in patients with atrial fibrillation

Control arm, standard of care

ACTIVE COMPARATOR

Pulmonary vein isolation will be performed with the pentaspline catheter in basket shape (4x) and flower shaped (4x) applications of the catheter.

Device: Pulmonary vein isolation by percutaneous endocardial catheter ablation using a pentaspline pulsed high voltage electrical field system in patients with atrial fibrillation

Interventions

Pulmonary vein isolation by percutaneous endocardial catheter ablation using the FARAPULSE pulsed high voltage electrical field system in patients with atrial fibrillation DEVICE

Standard of care 4 pulsed electrical field applications in basket shape and 4 applications in flower shape

Experimental arm, extra applications

Pulmonary vein isolation by percutaneous endocardial catheter ablation using a pentaspline pulsed high voltage electrical field system in patients with atrial fibrillation DEVICE

Experimental treatment delivering 2 pulsed electrical field applications in olive shape, 4 in basket shape and 6 applications in flower shape

Control arm, standard of care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• R&D Cardiologie: lead

Study Sites (1)

St. Antonius Hospital

Nieuwegein, 3435 CM, Netherlands

RECRUITING

Related Publications (25)

• 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.

  PMID: 37622592 BACKGROUND

• Kawamura I, Neuzil P, Shivamurthy P, Kuroki K, Lam J, Musikantow D, Chu E, Turagam MK, Minami K, Funasako M, Petru J, Choudry S, Miller MA, Langan MN, Whang W, Dukkipati SR, Koruth JS, Reddy VY. How does the level of pulmonary venous isolation compare between pulsed field ablation and thermal energy ablation (radiofrequency, cryo, or laser)? Europace. 2021 Nov 8;23(11):1757-1766. doi: 10.1093/europace/euab150.

  PMID: 34151947 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, 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.

  PMID: 29016840 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.

  PMID: 36842871 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.

  PMID: 35513354 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.

  PMID: 34538095 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.

  PMID: 31085321 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.

  PMID: 37161743 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.

  PMID: 33933412 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.

  PMID: 37634148 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.

  PMID: 37379528 BACKGROUND

• 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.

  PMID: 36877118 BACKGROUND

• 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.

  PMID: 36427201 BACKGROUND

• 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.

  PMID: 34240134 BACKGROUND

• Cochet H, Nakatani Y, Sridi-Cheniti S, Cheniti G, Ramirez FD, Nakashima T, Eggert C, Schneider C, Viswanathan R, Derval N, Duchateau J, Pambrun T, Chauvel R, Reddy VY, Montaudon M, Laurent F, Sacher F, Hocini M, Haissaguerre M, Jais P. Pulsed field ablation selectively spares the oesophagus during pulmonary vein isolation for atrial fibrillation. Europace. 2021 Sep 8;23(9):1391-1399. doi: 10.1093/europace/euab090.

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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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• 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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MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucas VA Boersma, MD, PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas VA Boersma, MD, PhD

CONTACT

+31883200900; L.boersma@antoniusziekenhuis.nl

Isabelle N Bax, MD

CONTACT

+31883200929; i.bax@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 13, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

NL (1)