NCT02665442|Unknown
Retracting the Esophagus During AF Ablation
EsoSure
Esophageal Stylet as a Strategy to Minimize the Risk of Esophageal Injury During the Atrial Fibrillation Catheter Ablation Procedure.
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EsoSure
Esophageal Stylet as a Strategy to Minimize the Risk of Esophageal Injury During the Atrial Fibrillation Catheter Ablation Procedure.
Sponsor study identifier
interventional
40
1 country
1
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This Study is designed to determine the outcome and effect of implementation of Esophageal Stylet as a strategy to minimize the risk of esophageal injury during the atrial fibrillation catheter ablation procedure.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
January 23, 2016
Actual (reported)January 27, 2016
Actual (reported)January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Esophageal injury or erosion
Decrease of esophageal thermal injury detected by esophageal Pill-Cam
2-3 days post ablation
Recurrence of Atrial Fibrillation
12 Months
Total radiofrequency time
Day of ablation procedure
This group will receive an Esophageal stylet; EsoSure during the ablation procedure in attempt of moving the esophagus away from the ablation site.
This group will receive the ablation procedure without any modifications or interventions. No esophageal stylet will be used in this group.
The Esophageal Stylet is a thin rigid tube, which will be inserted inside a commonly used nasogastric tube placed inside the esophagus during the ablation. We will use this stylet to move the esophagus away from the site of the ablation about 1-2 centimeters.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Yale New Haven Hospital
New Haven, Connecticut, 06520, United States
Mark Marieb, MD, FACC
Yale University
First Submitted
January 23, 2016
First Posted
January 27, 2016
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2018
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 27, 2016
Record last verified: 2016-01
Data will be shared through publications.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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