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Evaluation of the CIRCA Monitoring System in Prevention of Esophageal Lesions Following RFCA (CIRCA-EGD)

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ClinicalTrials.gov Identifier: NCT02467166
Recruitment Status : Recruiting
First Posted : June 9, 2015
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Circa Scientific
Information provided by (Responsible Party):
Gregory Kent Feld, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Circa™ Probe Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : June 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Circa™ Probe
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
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.
Other Names:
  • CIRCA
  • K112376




Primary Outcome Measures :
  1. The number of lesions, if any, will be counted to determine the efficacy of the Circa temperature probe in conjunction with the RFCA procedure in reducing lesion formation. [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467166


Contacts
Contact: Maylene Alegre, BHS 858-246-2406 malegre@ucsd.edu

Locations
United States, California
Sulpizio Cardiovascular Center Recruiting
La Jolla, California, United States, 92037
Contact: Jessica Hunter, BHS    858-246-2402    j2hunter@ucsd.edu   
Principal Investigator: Gregory Feld, MD         
Sponsors and Collaborators
University of California, San Diego
Circa Scientific
Investigators
Principal Investigator: Gregory Feld, MD UC San Diego

Publications of Results:

Other Publications:
Responsible Party: Gregory Kent Feld, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02467166     History of Changes
Other Study ID Numbers: 150018
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gregory Kent Feld, University of California, San Diego:
esophagoscopy
atrial fibrillation ablation
radio frequency catheter ablation
esophageal lesion
arrhythmia
atrial fibrillation
AF
esophageal damage

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes