Clinical trial NCT06364215 - References

Atrial Fibrillation Paroxysmal — Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation

Citation(s)

•   Abhayaratna WP, Seward JB, Appleton CP, Douglas PS, Oh JK, Tajik AJ, Tsang TS
  Left atrial size: physiologic determinants and clinical applications. J Am Coll Cardiol. 2006 Jun 20;47(12):2357-63. doi: 10.1016/j.jacc.2006.02.048.
•   Ahn J, Shin DG, Han SJ, Lim HE
  Does isolation of the left atrial posterior wall using cryoballoon ablation improve clinical outcomes in patients with persistent atrial fibrillation? A prospective randomized controlled trial. Europace. 2022 Jul 21;24(7):1093-1101. doi: 10.1093/europace/euac005.
•   Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne J, Roux JF, Yung D, Skanes A, Khaykin Y, Morillo C, Jolly U, Novak P, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Lauck S, Macle L, Verma A; EARLY-AF Investigators
  Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):305-315. doi: 10.1056/NEJMoa2029980. Epub 2020 Nov 16.
•   Aryana A, Allen SL, Pujara DK, Bowers MR, O'Neill PG, Yamauchi Y, Shigeta T, Vierra EC, Okishige K, Natale A
  Concomitant Pulmonary Vein and Posterior Wall Isolation Using Cryoballoon With Adjunct Radiofrequency in Persistent Atrial Fibrillation. JACC Clin Electrophysiol. 2021 Feb;7(2):187-196. doi: 10.1016/j.jacep.2020.08.016. Epub 2020 Oct 28.
•   Aryana A, Thiemann AM, Pujara DK, Cossette LL, Allen SL, Bowers MR, Gandhavadi M, Heath R, Trivedi AD, O'Neill PG, Ellis ER, d'Avila A
  Pulmonary Vein Isolation With and Without Posterior Wall Isolation in Paroxysmal Atrial Fibrillation: IMPPROVE-PAF Trial. JACC Clin Electrophysiol. 2023 May;9(5):628-637. doi: 10.1016/j.jacep.2023.01.014. Epub 2023 Mar 22.
•   Atienza F, Almendral J, Jalife J, Zlochiver S, Ploutz-Snyder R, Torrecilla EG, Arenal A, Kalifa J, Fernandez-Aviles F, Berenfeld O
  Real-time dominant frequency mapping and ablation of dominant frequency sites in atrial fibrillation with left-to-right frequency gradients predicts long-term maintenance of sinus rhythm. Heart Rhythm. 2009 Jan;6(1):33-40. doi: 10.1016/j.hrthm.2008.10.024. Epub 2008 Oct 22.
•   Castiello T, Georgiopoulos G, Finocchiaro G, Claudia M, Gianatti A, Delialis D, Aimo A, Prasad S
  COVID-19 and myocarditis: a systematic review and overview of current challenges. Heart Fail Rev. 2022 Jan;27(1):251-261. doi: 10.1007/s10741-021-10087-9. Epub 2021 Mar 24.
•   Chew DS, Jones KA, Loring Z, Black-Maier E, Noseworthy PA, Exner DV, Packer DL, Grant J, Mark DB, Piccini JP
  Diagnosis-to-ablation time predicts recurrent atrial fibrillation and rehospitalization following catheter ablation. Heart Rhythm O2. 2021 Nov 19;3(1):23-31. doi: 10.1016/j.hroo.2021.11.012. eCollection 2022 Feb.
•   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.
•   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.
•   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.
•   Ekanem E, Reddy VY, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T, Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D, Kautzner J, Vijgen J, Jais P, Petru J, Chun J, Roten L, Futing A, Rillig A, Mulder BA, Johannessen A, Rollin A, Lehrmann H, Sohns C, Jurisic Z, Savoure A, Combes S, Nentwich K, Gunawardene M, Ouss A, Kirstein B, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Turagam MK, Neuzil P; MANIFEST-PF Cooperative
  Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). Europace. 2022 Sep 1;24(8):1256-1266. doi: 10.1093/europace/euac050. Erratum In: Europace. 2023 Feb 16;25(2):449.
•   Fuller IA, Wood MA
  Intramural coronary vasculature prevents transmural radiofrequency lesion formation: implications for linear ablation. Circulation. 2003 Apr 8;107(13):1797-803. doi: 10.1161/01.CIR.0000058705.97823.F4. Epub 2003 Mar 24.
•   Hong J, Stewart MT, Cheek DS, Francischelli DE, Kirchhof N
  Cardiac ablation via electroporation. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:3381-4. doi: 10.1109/IEMBS.2009.5332816.
•   Huo Y, Gaspar T, Schonbauer R, Wojcik M, Fiedler L, Roithinger FX, Martinek M, Purerfellner H, Kirstein B, Richter U, Ulbrich S, Mayer J, Krahnefeld O, Agdirlioglu T, Zedda A, Piorkowski J, Piorkowski C
  Low-Voltage Myocardium-Guided Ablation Trial of Persistent Atrial Fibrillation. NEJM Evid. 2022 Nov;1(11):EVIDoa2200141. doi: 10.1056/EVIDoa2200141. Epub 2022 Oct 19.
•   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.
•   Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbuchel H, Hindricks G, Kautzner J, Kuck KH, Mont L, Ng GA, Rekosz J, Schoen N, Schotten U, Suling A, Taggeselle J, Themistoclakis S, Vettorazzi E, Vardas P, Wegscheider K, Willems S, Crijns HJGM, Breithardt G; EAST-AFNET 4 Trial Investigators
  Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29.
•   Kistler PM, Chieng D, Sugumar H, Ling LH, Segan L, Azzopardi S, Al-Kaisey A, Parameswaran R, Anderson RD, Hawson J, Prabhu S, Voskoboinik A, Wong G, Morton JB, Pathik B, McLellan AJ, Lee G, Wong M, Finch S, Pathak RK, Raja DC, Sterns L, Ginks M, Reid CM, Sanders P, Kalman JM
  Effect of Catheter Ablation Using Pulmonary Vein Isolation With vs Without Posterior Left Atrial Wall Isolation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation: The CAPLA Randomized Clinical Trial. JAMA. 2023 Jan 10;329(2):127-135. doi: 10.1001/jama.2022.23722.
•   Koruth JS, Kuroki K, Kawamura I, Stoffregen WC, Dukkipati SR, Neuzil P, Reddy VY
  Focal Pulsed Field Ablation for Pulmonary Vein Isolation and Linear Atrial Lesions: A Preclinical Assessment of Safety and Durability. Circ Arrhythm Electrophysiol. 2020 Jun;13(6):e008716. doi: 10.1161/CIRCEP.120.008716. Epub 2020 May 6.
•   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.
•   Kumar P, Bamimore AM, Schwartz JD, Chung EH, Gehi AK, Kiser AC, Hummel JP, Mounsey JP
  Challenges and Outcomes of Posterior Wall Isolation for Ablation of Atrial Fibrillation. J Am Heart Assoc. 2016 Sep 23;5(9):e003885. doi: 10.1161/JAHA.116.003885.
•   Lavee J, Onik G, Mikus P, Rubinsky B
  A novel nonthermal energy source for surgical epicardial atrial ablation: irreversible electroporation. Heart Surg Forum. 2007;10(2):E162-7. doi: 10.1532/HSF98.20061202.
•   Lee JM, Shim J, Park J, Yu HT, Kim TH, Park JK, Uhm JS, Kim JB, Joung B, Lee MH, Kim YH, Pak HN; POBI-AF Investigators
  The Electrical Isolation of the Left Atrial Posterior Wall in Catheter Ablation of Persistent Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Nov;5(11):1253-1261. doi: 10.1016/j.jacep.2019.08.021. Epub 2019 Oct 30. Erratum In: JACC Clin Electrophysiol. 2023 Jan;9(1):145.
•   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.
•   Loh P, van Es R, Groen MHA, Neven K, Kassenberg W, Wittkampf FHM, Doevendans PA
  Pulmonary Vein Isolation With Single Pulse Irreversible Electroporation: A First in Human Study in 10 Patients With Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2020 Oct;13(10):e008192. doi: 10.1161/CIRCEP.119.008192. Epub 2020 Sep 8.
•   Markman TM, Hyman MC, Kumareswaran R, Arkles JS, Santangeli P, Schaller RD, Supple GE, Frankel DS, Riley MP, Lin D, Garcia F, Dixit S, Callans DJ, Marchlinski FE, Nazarian S
  Durability of posterior wall isolation after catheter ablation among patients with recurrent atrial fibrillation. Heart Rhythm. 2020 Oct;17(10):1740-1744. doi: 10.1016/j.hrthm.2020.05.005. Epub 2020 May 7.
•   Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM
  Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18.
•   Nattel S, Burstein B, Dobrev D
  Atrial remodeling and atrial fibrillation: mechanisms and implications. Circ Arrhythm Electrophysiol. 2008 Apr;1(1):62-73. doi: 10.1161/CIRCEP.107.754564. No abstract available.
•   Nikolski VP, Efimov IR
  Electroporation of the heart. Europace. 2005 Sep;7 Suppl 2:146-54. doi: 10.1016/j.eupc.2005.04.011.
•   Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Poole JE, Noseworthy PA, Rosenberg YD, Jeffries N, Mitchell LB, Flaker GC, Pokushalov E, Romanov A, Bunch TJ, Noelker G, Ardashev A, Revishvili A, Wilber DJ, Cappato R, Kuck KH, Hindricks G, Davies DW, Kowey PR, Naccarelli GV, Reiffel JA, Piccini JP, Silverstein AP, Al-Khalidi HR, Lee KL; CABANA Investigators
  Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1261-1274. doi: 10.1001/jama.2019.0693.
•   Rahman F, Kwan GF, Benjamin EJ
  Global epidemiology of atrial fibrillation. Nat Rev Cardiol. 2016 Jul 14;13(8):501. doi: 10.1038/nrcardio.2016.114. No abstract available.
•   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.
•   Reddy VY, Anter E, Rackauskas G, Peichl P, Koruth JS, Petru J, Funasako M, Minami K, Natale A, Jais P, Nakagawa H, Marinskis G, Aidietis A, Kautzner J, Neuzil P
  Lattice-Tip Focal Ablation Catheter That Toggles Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation: A First-in-Human Trial. Circ Arrhythm Electrophysiol. 2020 Jun;13(6):e008718. doi: 10.1161/CIRCEP.120.008718. Epub 2020 May 8.
•   Reddy VY, Koruth J, Jais P, Petru J, Timko F, Skalsky I, Hebeler R, Labrousse L, Barandon L, Kralovec S, Funosako M, Mannuva BB, Sediva L, Neuzil P
  Ablation of Atrial Fibrillation With Pulsed Electric Fields: An Ultra-Rapid, Tissue-Selective Modality for Cardiac Ablation. JACC Clin Electrophysiol. 2018 Aug;4(8):987-995. doi: 10.1016/j.jacep.2018.04.005. Epub 2018 May 11.
•   Romero J, Gabr M, Alviz I, Briceno D, Diaz JC, Rodriguez D, Patel K, Polanco D, Trivedi C, Mohanty S, Della Rocca D, Lakkireddy D, Natale A, Di Biase L
  Focal impulse and rotor modulation guided ablation versus pulmonary vein isolation for atrial fibrillation: A meta-analysis of head-to-head comparative studies. J Cardiovasc Electrophysiol. 2021 Jul;32(7):1822-1832. doi: 10.1111/jce.15036. Epub 2021 May 27.
•   Romero J, Polanco D, Gabr M, Alviz I, Diaz JC, Briceno D, Velasco A, Patel K, Natale A, Di Biase L
  Posterior Wall Electrical Isolation in Patients Undergoing Catheter Ablation for Paroxysmal and Nonparoxysmal Atrial Fibrillation. JACC Clin Electrophysiol. 2023 Apr;9(4):583-585. doi: 10.1016/j.jacep.2022.11.007. Epub 2023 Jan 18. No abstract available.
•   Steiger NA, Romero JE
  Pulsed-field ablation: What are the unknowns and when will they cease to concern us? J Cardiovasc Electrophysiol. 2022 Jul;33(7):1489-1493. doi: 10.1111/jce.15521. Epub 2022 May 25. No abstract available.
•   Stewart MT, Haines DE, Verma A, Kirchhof N, Barka N, Grassl E, Howard B
  Intracardiac pulsed field ablation: Proof of feasibility in a chronic porcine model. Heart Rhythm. 2019 May;16(5):754-764. doi: 10.1016/j.hrthm.2018.10.030. Epub 2018 Oct 30.
•   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.
•   Tovar O, Tung L
  Electroporation of cardiac cell membranes with monophasic or biphasic rectangular pulses. Pacing Clin Electrophysiol. 1991 Nov;14(11 Pt 2):1887-92. doi: 10.1111/j.1540-8159.1991.tb02785.x.
•   Turagam MK, Neuzil P, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T, Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D, Kautzner J, Vijgen J, Jais P, Petru J, Chun J, Roten L, Futing A, Lemoine MD, Ruwald M, Mulder BA, Rollin A, Lehrmann H, Fink T, Jurisic Z, Chaumont C, Adelino R, Nentwich K, Gunawardene M, Ouss A, Heeger CH, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Kueffer T, Rahe G, Reddy VY
  Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry. Circulation. 2023 Jul 4;148(1):35-46. doi: 10.1161/CIRCULATIONAHA.123.064959. Epub 2023 May 18.
•   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.
•   Wazni OM, Dandamudi G, Sood N, Hoyt R, Tyler J, Durrani S, Niebauer M, Makati K, Halperin B, Gauri A, Morales G, Shao M, Cerkvenik J, Kaplon RE, Nissen SE; STOP AF First Trial Investigators
  Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):316-324. doi: 10.1056/NEJMoa2029554. Epub 2020 Nov 16.
•   Wittkampf FH, van Driel VJ, van Wessel H, Neven KG, Grundeman PF, Vink A, Loh P, Doevendans PA
  Myocardial lesion depth with circular electroporation ablation. Circ Arrhythm Electrophysiol. 2012 Jun 1;5(3):581-6. doi: 10.1161/CIRCEP.111.970079. Epub 2012 Apr 6.
•   Wittkampf FH, van Driel VJ, van Wessel H, Vink A, Hof IE, Grundeman PF, Hauer RN, Loh P
  Feasibility of electroporation for the creation of pulmonary vein ostial lesions. J Cardiovasc Electrophysiol. 2011 Mar;22(3):302-9. doi: 10.1111/j.1540-8167.2010.01863.x.
•   Yavin H, Shapira-Daniels A, Barkagan M, Sroubek J, Shim D, Melidone R, Anter E
  Pulsed Field Ablation Using a Lattice Electrode for Focal Energy Delivery: Biophysical Characterization, Lesion Durability, and Safety Evaluation. Circ Arrhythm Electrophysiol. 2020 Jun;13(6):e008580. doi: 10.1161/CIRCEP.120.008580. Epub 2020 May 6.

Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation

Details for clinical trial NCT06364215