Relationship Between the Posterior Atrial Wall and the Esophagus: Esophageal Position and Temperature MEasurement During Atrial Fibrillation Ablation.

NCT04394923 | Completed

• 1 other identifier: AWESOME-AF
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

A multimodal strategy integrating esophageal visualization with the multidetector computed tomography (MDCT) and simultaneous temperature monitoring has never been put into practice. We have developed an isodistance map (esophageal print) to depict the atrio-esophageal relationship and to analyze the esophageal position peri procedurally. The present randomized study intends to analyze the usefulness of the esophageal print in predicting local thermal heating of the esophagus.

Conditions

Atrial Arrhythmia

Keywords

Atrial fibrillation; Atypical flutter; catheter-based ablation; radiofrequency ablation; left atrial wall thickness; atrio-esophageal relationship

Outcome Measures

Primary Outcomes (1)

• Proportion of participants presenting a temperature rise as measured with a luminal esophageal temperature probe during radiofrequency delivery. The temperature is measured in Celsius degrees.

  Number of intraesophageal temperature rises above 39°C or absolute temperature raises of 2°C degrees. The chosen probe is St Jude

  1 day

Secondary Outcomes (1)

• Proportion of patients needing ablation power or ablation time modification owing to esophageal presence in the immediate posterior wall .

  1 day

Study Arms (2)

Intervention group or "PRINT" group

EXPERIMENTAL

The ablation line previously drawn will be modified regarding the esophageal print position in order to avoid RF application within the red layer of the esophageal print, which is the zone where the atrioesophageal distance is shorter. The maximal distance and the area between the original line and the modified line will be noted. In cases when ablation through the red layer is unavoidable, the delivered energy can be lowered to an ablation index (AI) of 300 regardless of the local wall thickness. If the temperature rises above 39℃, ablation will be immediately stopped, and energy will be reduced.

Procedure: Modification of the pulmonary vein ablation line

Control group

OTHER

The ablation line will not be modified from the original one drawn before randomization and RF applications will follow the regular path. If the temperature rises above 39℃, ablation will be immediately stopped, and energy will be reduced.

Procedure: Regular PVI ablation

Interventions

Modification of the pulmonary vein ablation line PROCEDURE

The ablation line previously drawn will be modified regarding the esophageal print position in order to avoid RF application within the red layer of the esophageal print.

Intervention group or "PRINT" group

Regular PVI ablation PROCEDURE

Blinded to the esophageal position based on the type of AF, closer to the ostium for paroxysmal AF and wider for persistent AF

Control group

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years.
• Indication for any atrial fibrillation or left atrial flutter ablation procedure.
• Documented episodes of atrial arrhythmia (AF/AT/AFL)
• Signed informed consent.

You may not qualify if:

• Age \< 18 years.
• Pregnancy.
• Impossibility to perform CT Scan.
• Impossibility to perform transesophageal echocardiography or to insert esophageal temperature monitoring probe.
• Concomitant investigation treatments.
• Medical, geographical and social factors that make study participation impractical
• Inability to give written informed consent.
• Patient's refusal to participate in the study.

Sponsors & Collaborators

• Centro Medico Teknon: lead

Study Sites (1)

Teknon Medical Center

Barcelona, 08017, Spain

Location

Related Publications (16)

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• Lakkireddy D, Reddy YM, Atkins D, Rajasingh J, Kanmanthareddy A, Olyaee M, Dusing R, Pimentel R, Bommana S, Dawn B. Effect of atrial fibrillation ablation on gastric motility: the atrial fibrillation gut study. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):531-6. doi: 10.1161/CIRCEP.114.002508. Epub 2015 Mar 14.

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• Lemola K, Sneider M, Desjardins B, Case I, Han J, Good E, Tamirisa K, Tsemo A, Chugh A, Bogun F, Pelosi F Jr, Kazerooni E, Morady F, Oral H. Computed tomographic analysis of the anatomy of the left atrium and the esophagus: implications for left atrial catheter ablation. Circulation. 2004 Dec 14;110(24):3655-60. doi: 10.1161/01.CIR.0000149714.31471.FD. Epub 2004 Nov 29.

  PMID: 15569839 BACKGROUND

• Tsao HM, Wu MH, Higa S, Lee KT, Tai CT, Hsu NW, Chang CY, Chen SA. Anatomic relationship of the esophagus and left atrium: implication for catheter ablation of atrial fibrillation. Chest. 2005 Oct;128(4):2581-7. doi: 10.1378/chest.128.4.2581.

  PMID: 16236927 BACKGROUND

• Kennedy R, Good E, Oral H, Huether E, Bogun F, Pelosi F, Morady F, Chugh A. Temporal stability of the location of the esophagus in patients undergoing a repeat left atrial ablation procedure for atrial fibrillation or flutter. J Cardiovasc Electrophysiol. 2008 Apr;19(4):351-5. doi: 10.1111/j.1540-8167.2007.01051.x. Epub 2007 Dec 12.

  PMID: 18081769 BACKGROUND

• Starek Z, Lehar F, Jez J, Scurek M, Wolf J, Kulik T, Zbankova A. Esophageal positions relative to the left atrium; data from 293 patients before catheter ablation of atrial fibrillation. Indian Heart J. 2018 Jan-Feb;70(1):37-44. doi: 10.1016/j.ihj.2017.06.013. Epub 2017 Jun 29.

  PMID: 29455785 BACKGROUND

• Barbhaiya CR, Kumar S, Guo Y, Zhong J, John RM, Tedrow UB, Koplan BA, Epstein LM, Stevenson WG, Michaud GF. Global Survey of Esophageal Injury in Atrial Fibrillation Ablation: Characteristics and Outcomes of Esophageal Perforation and Fistula. JACC Clin Electrophysiol. 2016 Apr;2(2):143-150. doi: 10.1016/j.jacep.2015.10.013. Epub 2015 Dec 23.

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• Halbfass P, Pavlov B, Muller P, Nentwich K, Sonne K, Barth S, Hamm K, Fochler F, Mugge A, Lusebrink U, Kuhn R, Deneke T. Progression From Esophageal Thermal Asymptomatic Lesion to Perforation Complicating Atrial Fibrillation Ablation: A Single-Center Registry. Circ Arrhythm Electrophysiol. 2017 Aug;10(8):e005233. doi: 10.1161/CIRCEP.117.005233.

  PMID: 28798021 BACKGROUND

• Kapur S, Barbhaiya C, Deneke T, Michaud GF. Esophageal Injury and Atrioesophageal Fistula Caused by Ablation for Atrial Fibrillation. Circulation. 2017 Sep 26;136(13):1247-1255. doi: 10.1161/CIRCULATIONAHA.117.025827.

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• Zellerhoff S, Ullerich H, Lenze F, Meister T, Wasmer K, Monnig G, Kobe J, Milberg P, Bittner A, Domschke W, Breithardt G, Eckardt L. Damage to the esophagus after atrial fibrillation ablation: Just the tip of the iceberg? High prevalence of mediastinal changes diagnosed by endosonography. Circ Arrhythm Electrophysiol. 2010 Apr;3(2):155-9. doi: 10.1161/CIRCEP.109.915918. Epub 2010 Mar 1.

  PMID: 20194799 BACKGROUND

• Kadado AJ, Akar JG, Hummel JP. Luminal esophageal temperature monitoring to reduce esophageal thermal injury during catheter ablation for atrial fibrillation: A review. Trends Cardiovasc Med. 2019 Jul;29(5):264-271. doi: 10.1016/j.tcm.2018.09.010. Epub 2018 Sep 19.

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• Kaneshiro T, Matsumoto Y, Nodera M, Kamioka M, Kamiyama Y, Yoshihisa A, Ohkawara H, Suzuki H, Takeishi Y. Anatomical predisposing factors of transmural thermal injury after pulmonary vein isolation. Europace. 2018 Jul 1;20(7):1122-1128. doi: 10.1093/europace/eux185.

  PMID: 28605437 BACKGROUND

• Kottkamp H, Piorkowski C, Tanner H, Kobza R, Dorszewski A, Schirdewahn P, Gerds-Li JH, Hindricks G. Topographic variability of the esophageal left atrial relation influencing ablation lines in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2005 Feb;16(2):146-50. doi: 10.1046/j.1540-8167.2005.40604.x.

  PMID: 15720452 BACKGROUND

• Teres C, Soto-Iglesias D, Penela D, Falasconi G, Viveros D, Meca-Santamaria J, Bellido A, Alderete J, Chauca A, Ordonez A, Marti-Almor J, Scherer C, Panaro A, Carballo J, Camara O, Ortiz-Perez JT, Berruezo A. Relationship between the posterior atrial wall and the esophagus: esophageal position and temperature measurement during atrial fibrillation ablation (AWESOME-AF). A randomized controlled trial. J Interv Card Electrophysiol. 2022 Dec;65(3):651-661. doi: 10.1007/s10840-022-01302-0. Epub 2022 Jul 21.

  PMID: 35861901 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Arrhytmia Unit

Model Details: Single center, prospective, randomized pilot study

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 20, 2020
• Study Start: June 22, 2020
• Primary Completion: March 15, 2021
• Study Completion: January 15, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)