Evaluation of the CIRCA Monitoring System in Prevention of Esophageal Lesions Following RFCA
| Status: | Recruiting |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2018 |
| Start Date: | June 2015 |
| End Date: | October 2018 |
| Contact: | Maylene Alegre, BHS |
| Email: | malegre@ucsd.edu |
| Phone: | 858-246-2406 |
A Prospective, Non-Randomized Study to Evaluate the CIRCA Esophageal Temperature Monitoring System in Prevention of Esophageal Lesions Following Atrial Fibrillation Radiofrequency Catheter Ablation
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.
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.
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.
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.
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
We found this trial at
1
site
La Jolla, California 92037
Principal Investigator: Gregory Feld, MD
Phone: 858-246-2402
Click here to add this to my saved trials
