Evaluation of the CIRCA Monitoring System in Prevention of Esophageal Lesions Following RFCA

Atrial Fibrillation Clinical Trial

— CIRCA-EGD  

Official title:

A Prospective, Non-Randomized Study to Evaluate the CIRCA Esophageal Temperature Monitoring System in Prevention of Esophageal Lesions Following Atrial Fibrillation Radiofrequency Catheter Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467166
• Other study ID #: 150018
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: May 5, 2020

Study information

• Verified date: May 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the use of Circa™ temperature monitoring system during ablation procedures will reduce the risk of esophageal lesions or damage. Esophageal lesions caused by ablation could later develop into a potentially fatal atrio-esophageal fistula, which is hole between the upper chamber of the heart and the esophagus. Although development of atrio-esophageal fistula following atrial fibrillation ablation is extremely rare, the complication is severe and potentially life-threatening. Therefore, monitoring of esophageal temperatures has been adopted to prevent the development of esophageal lesions. The Circa™ temperature monitoring system allows cardiac electrophysiologists to monitor and thereby limit temperatures as well as duration of ablation in the esophagus throughout the procedure.

Description:

Dr. Gregory Feld, M.D. is conducting a research study to find out more about the short-term effects on the esophagus of left atrial ablation (guided by Circa™ esophageal temperature monitoring system). The financial supporter of this study is Circa Scientific, LLC.

When the investigators perform a radiofrequency catheter ablation (RFCA) at UCSD, the investigators routinely use the Circa™ temperature monitor system to prevent damage to the esophagus. For this study, patients will receive an esophagoscopy, a procedure in which a flexible tube with a camera is inserted through the mouth into the esophagus. The esophagoscopy will be conducted the next day following the ablation procedure to examine the lining of the esophagus for possible lesions or damage. Patients are asked to participate in this study because they are scheduled to have an ablation for atrial fibrillation (AF). There will be approximately 40 participants in this study at the University of California, San Diego (UCSD) Cardiovascular Center. The use of the Circa™ temperature monitoring system used in standard ablation procedures at UCSD and will be used whether or not patients decide to participate in this study. Using esophagoscopy, this study will evaluate the lining of the esophagus, or swallowing tube between the throat and stomach, the day following atrial fibrillation ablation by using an endoscope, flexible tube equipped with a camera.

Patients enrolled in the study will proceed to their standard of care ablation procedure for treatment of atrial fibrillation. There will be no changes to the ablation as part of this research study. The Circa™ temperature monitor system will be used throughout the ablation as is standard clinical care for all patients receiving AF ablations at UCSD. For research purposes only, patients will undergo an esophagoscopy, or endoscopic evaluation of the esophagus, the next day following the atrial fibrillation ablation. This procedure will take 40-45 minutes, and will involve inserting a flexible probe (tube) with a camera, into the throat and esophagus (swallowing tube), where it will be inspected for any damage (thermal lesions) caused during the ablation procedure.

Following the procedure, patients will be monitored in the usual fashion in the procedure treatment unit (PTU), as is standard of care following AF ablation. Ablation patients will be discharged from the hospital in a standard manner after esophagoscopy and asked to schedule a follow-up appointment following ablation, as is standard of care. There will not be any research follow-up for this study. If for any reason patients cannot complete the ablation or esophagoscopy procedure, patient will be withdrawn from study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 5, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have atrial fibrillation and be scheduled for AF ablation, during which the Circa esophageal temperature probe will be used to guide ablation.

• Must give written informed consent

Exclusion Criteria:

• Patient's refusal to participate in the study

• Any known esophageal disease or prior injury that would preclude esophagoscopy

• Any complications occuring during or after AF ablation that would result in esophagoscopy being an added significant risk to the patient beyond the known potential risks from the esophagoscopy

• Prior AF ablation

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Circa™ Probe
The Circa™ probe will be used to monitor esophageal temperature and guide ablation power and duration during the RFCA procedure. Following ablation esophagoscopy will be performed to assess for esophageal lesions.

Locations

Country	Name	City	State
United States	Sulpizio Cardiovascular Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Circa Scientific

Country where clinical trial is conducted

United States, 

References & Publications (8)

ASGE Standards of Practice Committee, Evans JA, Early DS, Fukami N, Ben-Menachem T, Chandrasekhara V, Chathadi KV, Decker GA, Fanelli RD, Fisher DA, Foley KQ, Hwang JH, Jain R, Jue TL, Khan KM, Lightdale J, Malpas PM, Maple JT, Pasha SF, Saltzman JR, Sharaf RN, Shergill A, Dominitz JA, Cash BD; Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy. The role of endoscopy in Barrett's esophagus and other premalignant conditions of the esophagus. Gastrointest Endosc. 2012 Dec;76(6):1087-94. doi: 10.1016/j.gie.2012.08.004. — View Citation

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. — View Citation

Dagres N, Anastasiou-Nana M. Prevention of atrial-esophageal fistula after catheter ablation of atrial fibrillation. Curr Opin Cardiol. 2011 Jan;26(1):1-5. doi: 10.1097/HCO.0b013e328341387d. Review. — View Citation

Feld GK, Tate C, Hsu J. Esophageal temperature monitoring during AF ablation: multi-sensor or single-sensor probe? J Cardiovasc Electrophysiol. 2013 Dec;24(12):E24. doi: 10.1111/jce.12305. Epub 2013 Nov 14. — View Citation

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. — View Citation

Martinek M, Bencsik G, Aichinger J, Hassanein S, Schoefl R, Kuchinka P, Nesser HJ, Purerfellner H. Esophageal damage during radiofrequency ablation of atrial fibrillation: impact of energy settings, lesion sets, and esophageal visualization. J Cardiovasc Electrophysiol. 2009 Jul;20(7):726-33. doi: 10.1111/j.1540-8167.2008.01426.x. Epub 2009 Feb 2. — View Citation

Sause A, Tutdibi O, Pomsel K, Dinh W, Füth R, Lankisch M, Glosemeyer-Allhoff T, Janssen J, Müller M. Limiting esophageal temperature in radiofrequency ablation of left atrial tachyarrhythmias results in low incidence of thermal esophageal lesions. BMC Cardiovasc Disord. 2010 Oct 26;10:52. doi: 10.1186/1471-2261-10-52. — View Citation

Zellerhoff S, Ullerich H, Lenze F, Meister T, Wasmer K, Mönnig G, Köbe 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Esophageal Lesions.	The number of esophageal lesions observed by esophageal endoscopy after left atrial radiofrequency catheter ablation for atrial fibrillation.	Day 1