Clinical trial NCT03832959 - References

Atrial Fibrillation — Esophageal Damage Protection During Pulmonary Vein Ablation. Pilot Study.

Citation(s)

•   10
  5935/abc.20160078
•   Arruda MS, Armaganijan L, Di Biase L, Rashidi R, Natale A
  Feasibility and safety of using an esophageal protective system to eliminate esophageal thermal injury: implications on atrial-esophageal fistula following AF ablation. J Cardiovasc Electrophysiol. 2009 Nov;20(11):1272-8. doi: 10.1111/j.1540-8167.2009.01536.x. Epub 2009 Jun 30.
•   Berjano EJ, Hornero F
  A cooled intraesophageal balloon to prevent thermal injury during endocardial surgical radiofrequency ablation of the left atrium: a finite element study. Phys Med Biol. 2005 Oct 21;50(20):N269-79. Epub 2005 Sep 27.
•   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. J Arrhythm. 2017 Oct;33(5):369-409. doi: 10.1016/j.joa.2017.08.001. Epub 2017 Sep 15.
•   Carroll BJ, Contreras-Valdes FM, Heist EK, Barrett CD, Danik SB, Ruskin JN, Mansour M
  Multi-sensor esophageal temperature probe used during radiofrequency ablation for atrial fibrillation is associated with increased intraluminal temperature detection and increased risk of esophageal injury compared to single-sensor probe. J Cardiovasc Electrophysiol. 2013 Sep;24(9):958-64. doi: 10.1111/jce.12180. Epub 2013 Jun 7.
•   Deneke T, Bünz K, Bastian A, Päsler M, Anders H, Lehmann R, Meuser W, de Groot JR, Horlitz M, Haberkorn R, Mügge A, Shin DI
  Utility of esophageal temperature monitoring during pulmonary vein isolation for atrial fibrillation using duty-cycled phased radiofrequency ablation. J Cardiovasc Electrophysiol. 2011 Mar;22(3):255-61. doi: 10.1111/j.1540-8167.2010.01916.x. Epub 2010 Oct 11.
•   Goury A, Voicu S, Deye N
  Reply letter to: Targeted temperature management using the "Esophageal Cooling Device" after cardiac arrest (the COOL study): A feasibility and safety study. Resuscitation. 2018 Feb;123:e7-e8. doi: 10.1016/j.resuscitation.2017.12.001.
•   Halm U, Gaspar T, Zachäus M, Sack S, Arya A, Piorkowski C, Knigge I, Hindricks G, Husser D
  Thermal esophageal lesions after radiofrequency catheter ablation of left atrial arrhythmias. Am J Gastroenterol. 2010 Mar;105(3):551-6. doi: 10.1038/ajg.2009.625. Epub 2009 Nov 3.
•   Hegazy AF, Lapierre DM, Butler R, Althenayan E
  Temperature control in critically ill patients with a novel esophageal cooling device: a case series. BMC Anesthesiol. 2015 Oct 19;15:152. doi: 10.1186/s12871-015-0133-6.
•   Hegazy AF, Lapierre DM, Butler R, Martin J, Althenayan E
  The esophageal cooling device: A new temperature control tool in the intensivist's arsenal. Heart Lung. 2017 May - Jun;46(3):143-148. doi: 10.1016/j.hrtlng.2017.03.001. Epub 2017 Apr 11.
•   Hornero F, Berjano EJ
  Atrial ablation and esophageal injury: comments on an experimental study. J Thorac Cardiovasc Surg. 2006 Jul;132(1):212-3; author reply 213-4.
•   Kalasbail P, Makarova N, Garrett F, Sessler DI
  Heating and Cooling Rates With an Esophageal Heat Exchange System. Anesth Analg. 2018 Apr;126(4):1190-1195. doi: 10.1213/ANE.0000000000002691.
•   Khan I, Haymore J, Barnaba B, Armahizer M, Melinosky C, Bautista MA, Blaber B, Chang WT, Parikh G, Motta M, Badjatia N
  Esophageal Cooling Device Versus Other Temperature Modulation Devices for Therapeutic Normothermia in Subarachnoid and Intracranial Hemorrhage. Ther Hypothermia Temp Manag. 2018 Mar;8(1):53-58. doi: 10.1089/ther.2017.0033. Epub 2017 Dec 13.
•   Khan, I
  et al. in 14th Annual Neurocritical Care Society Meeting (National Harbor, MD, 2016).
•   Knopp H, Halm U, Lamberts R, Knigge I, Zachäus M, Sommer P, Richter S, Bollmann A, Hindricks G, Husser D
  Incidental and ablation-induced findings during upper gastrointestinal endoscopy in patients after ablation of atrial fibrillation: a retrospective study of 425 patients. Heart Rhythm. 2014 Apr;11(4):574-8. doi: 10.1016/j.hrthm.2014.01.010. Epub 2014 Jan 10.
•   Kuwahara T, Takahashi A, Okubo K, Takagi K, Yamao K, Nakashima E, Kawaguchi N, Takigawa M, Watari Y, Sugiyama T, Handa K, Kimura S, Hikita H, Sato A, Aonuma K
  Oesophageal cooling with ice water does not reduce the incidence of oesophageal lesions complicating catheter ablation of atrial fibrillation: randomized controlled study. Europace. 2014 Jun;16(6):834-9. doi: 10.1093/europace/eut368. Epub 2014 Jan 26.
•   Leite LR, Santos SN, Maia H, Henz BD, Giuseppin F, Oliverira A, Zanatta AR, Peres AK, Novakoski C, Barreto JR, Vassalo F, d'Avila A, Singh SM
  Luminal esophageal temperature monitoring with a deflectable esophageal temperature probe and intracardiac echocardiography may reduce esophageal injury during atrial fibrillation ablation procedures: results of a pilot study. Circ Arrhythm Electrophysiol. 2011 Apr;4(2):149-56. doi: 10.1161/CIRCEP.110.960328. Epub 2011 Feb 15.
•   Lequerica JL, Berjano EJ, Herrero M, Hornero F
  Reliability assessment of a cooled intraesophageal balloon to prevent thermal injury during RF cardiac ablation: an agar phantom study. J Cardiovasc Electrophysiol. 2008 Nov;19(11):1188-93. doi: 10.1111/j.1540-8167.2008.01229.x. Epub 2008 Jun 4.
•   Lequerica JL, Berjano EJ, Herrero M, Melecio L, Hornero F
  A cooled water-irrigated intraesophageal balloon to prevent thermal injury during cardiac ablation: experimental study based on an agar phantom. Phys Med Biol. 2008 Feb 21;53(4):N25-34. doi: 10.1088/0031-9155/53/4/N01. Epub 2008 Jan 16.
•   Liu E, Shehata M, Liu T, Amorn A, Cingolani E, Kannarkat V, Chugh SS, Wang X
  Prevention of esophageal thermal injury during radiofrequency ablation for atrial fibrillation. J Interv Card Electrophysiol. 2012 Oct;35(1):35-44. doi: 10.1007/s10840-011-9655-0. Epub 2012 Jun 21. Review.
•   Markota A, Fluher J, Kit B, Balažic P, Sinkovic A
  The introduction of an esophageal heat transfer device into a therapeutic hypothermia protocol: A prospective evaluation. Am J Emerg Med. 2016 Apr;34(4):741-5. doi: 10.1016/j.ajem.2016.01.028. Epub 2016 Jan 28.
•   Markota A, Kit B, Fluher J, Sinkovic A
  Use of an oesophageal heat transfer device in therapeutic hypothermia. Resuscitation. 2015 Apr;89:e1-2. doi: 10.1016/j.resuscitation.2015.01.032. Epub 2015 Feb 7.
•   Markota A, Košir AS, Balažic P, Živko I, Sinkovic A
  A Novel Esophageal Heat Transfer Device for Temperature Management in an Adult Patient with Severe Meningitis. J Emerg Med. 2017 Jan;52(1):e27-e28. doi: 10.1016/j.jemermed.2016.07.086. Epub 2016 Sep 19.
•   Markota, A
  , Fluher, J., Balazic, P., Kit, B. & Sinkovic, A. Therapeutic hypothermia with esophageal heat transfer device. Resuscitation. 96 138, doi:10.1016/j.resuscitation.2015.09.328, (2015).
•   Naiman M, Shanley P, Garrett F, Kulstad E
  Evaluation of advanced cooling therapy's esophageal cooling device for core temperature control. Expert Rev Med Devices. 2016 May;13(5):423-33. doi: 10.1080/17434440.2016.1174573. Epub 2016 Apr 15.
•   Naiman MI, Gray M, Haymore J, Hegazy AF, Markota A, Badjatia N, Kulstad EB
  Esophageal Heat Transfer for Patient Temperature Control and Targeted Temperature Management. J Vis Exp. 2017 Nov 21;(129). doi: 10.3791/56579.
•   Naiman, M
  et al. An evaluation of esophageal temperature management in cases longer than 72 hours. Resuscitation. 118 e82, doi:10.1016/j.resuscitation.2017.08.198, (2017).
•   Nair GM, Nery PB, Redpath CJ, Lam BK, Birnie DH
  Atrioesophageal fistula in the era of atrial fibrillation ablation: a review. Can J Cardiol. 2014 Apr;30(4):388-95. doi: 10.1016/j.cjca.2013.12.012. Epub 2013 Dec 20. Review.
•   Primožic KK, Svenšek F, Markota A, Sinkovic A
  Rewarming After Severe Accidental Hypothermia Using the Esophageal Heat Transfer Device: A Case Report. Ther Hypothermia Temp Manag. 2018 Mar;8(1):62-64. doi: 10.1089/ther.2017.0017. Epub 2017 Sep 21.
•   Scanavacca, M
  I. et al. in ESC Congress 2007, 1 - 5 September Vol. 28 156 (Vienna, Austria, 2007).
•   Sohara H, Satake S, Takeda H, Yamaguchi Y, Nagasu N
  Prevalence of esophageal ulceration after atrial fibrillation ablation with the hot balloon ablation catheter: what is the value of esophageal cooling? J Cardiovasc Electrophysiol. 2014 Jul;25(7):686-92. doi: 10.1111/jce.12394. Epub 2014 Mar 24.
•   Tschabrunn CM, Silverstein J, Berzin T, Ellis E, Buxton AE, Josephson ME, Anter E
  Comparison between single- and multi-sensor oesophageal temperature probes during atrial fibrillation ablation: thermodynamic characteristics. Europace. 2015 Jun;17(6):891-7. doi: 10.1093/europace/euu356. Epub 2015 Mar 15.
•   Tsuchiya T, Ashikaga K, Nakagawa S, Hayashida K, Kugimiya H
  Atrial fibrillation ablation with esophageal cooling with a cooled water-irrigated intraesophageal balloon: a pilot study. J Cardiovasc Electrophysiol. 2007 Feb;18(2):145-50. Epub 2006 Dec 1.
•   Tzou WS, Russo AM
  Luminal esophageal temperature monitoring for the prevention of esophageal injury during left atrial ablation: LET it be? J Cardiovasc Electrophysiol. 2013 Sep;24(9):965-7. doi: 10.1111/jce.12198. Epub 2013 Jul 19.
•   Vaezi MF, Pandolfino JE, Vela MF
  ACG clinical guideline: diagnosis and management of achalasia. Am J Gastroenterol. 2013 Aug;108(8):1238-49; quiz 1250. doi: 10.1038/ajg.2013.196. Epub 2013 Jul 23.
•   Wayne, M
  The Esophageal Cooling Device: A New Way to Achieve Targeted Temperature Management. J Cardiol & Cardiovasc Ther. 5 (1), doi:10.19080/JOCCT.2017.05.555651, (2017).
•   Williams D, Leslie G, Kyriazis D, O'Donovan B, Bowes J, Dingley J
  Use of an Esophageal Heat Exchanger to Maintain Core Temperature during Burn Excisions and to Attenuate Pyrexia on the Burns Intensive Care Unit. Case Rep Anesthesiol. 2016;2016:7306341. doi: 10.1155/2016/7306341. Epub 2016 Feb 25.
•   Zargar SA, Kochhar R, Mehta S, Mehta SK
  The role of fiberoptic endoscopy in the management of corrosive ingestion and modified endoscopic classification of burns. Gastrointest Endosc. 1991 Mar-Apr;37(2):165-9.
•   Zivko, I
  , Balazic, P., Markota, A. & Sinkovic, A. in 12th Emirates Critical Care Conference (Dubai, UAE, 2016).

Evaluation of Esophageal Damage During Conventional Pulmonary Vein Ablation Procedures and Potential Strategies to Protect the Esophagus. Pilot Study.

Details for clinical trial NCT03832959