What is the purpose of this trial?
You are being asked to take part in a research study designed to collect information about temperature changes in a patient’s esophagus (food pipe) while they are undergoing a cardiac ablation. The purpose of this research study is to better define safe esophageal (the tube that goes to your stomach) temperatures that may be reached without causing thermal injury during ablation. Catheter ablation for atrial fibrillation has been associated with complications such as atrio-esophageal fistula (a hole that forms between the left atrium and the esophagus) and gastroparesis (slow emptying of food out of the stomach). These are believed to result from collateral thermal injury to the nearby esophagus and nerves running along the outside of the esophagus. In this study we will record the esophageal temperature profiles during ablation, and perform upper endoscopy to look for any visible thermal injury before you leave the hospital. The temperature profiles will be recorded using the Securus temperature catheter which will be inserted into the esophagus prior to the procedure instead of the standard core body temperature probe used at this center. No changes to the treatment of subjects will be required. This newly approved esophageal temperature probe is the same size as the standard temperature probe currently used.
Ages: 18 - 80 years
Yale University School of Medicine
Dates: 12/01/2016 - 12/31/2017
Last Updated: 02/22/2018
Study HIC#: 2000020007