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

NCT02467166 | Completed Results

• 1 other identifier: 150018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

esophagoscopy; atrial fibrillation ablation; radio frequency catheter ablation; esophageal lesion; arrhythmia; atrial fibrillation; AF; esophageal damage

Outcome Measures

Primary Outcomes (1)

• Number of Esophageal Lesions.

  The number of esophageal lesions observed by esophageal endoscopy after left atrial radiofrequency catheter ablation for atrial fibrillation.

  Day 1

Study Arms (1)

Circa™ Probe

EXPERIMENTAL

The Circa™ Probe will be used during the RFCA to monitor esophageal temperature. Following ablation, the esophagoscopy will be performed to examine the esophagus for resulting thermal lesions.

Device: Circa™ Probe

Interventions

Circa™ Probe DEVICE

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.

Also known as: CIRCA, K112376

Circa™ Probe

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Circa Scientific, Inc.: collaborator

Study Sites (1)

Sulpizio Cardiovascular Center

La Jolla, California, 92037, United States

Location

Related Publications (8)

• 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.

  PMID: 19207781 BACKGROUND

• 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.

  PMID: 21099683 BACKGROUND

• Halm U, Gaspar T, Zachaus 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.

  PMID: 19888201 BACKGROUND

• Sause A, Tutdibi O, Pomsel K, Dinh W, Futh R, Lankisch M, Glosemeyer-Allhoff T, Janssen J, Muller 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.

  PMID: 20977747 BACKGROUND

• 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

• 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.

  PMID: 23746064 BACKGROUND

• 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. No abstract available.

  PMID: 24118278 BACKGROUND

• 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. No abstract available.

  PMID: 23164510 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Gregory K. Feld, MD, Director CCEP
• Organization: University of California, San Diego Health System

gfeld@health.ucsd.edu

(858) 246-2972

Study Officials

• Gregory Feld, MD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 9, 2015
• Study Start: June 1, 2015
• Primary Completion: March 30, 2020
• Study Completion: May 5, 2020
• Last Updated: June 2, 2021
• Results First Posted: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)