Atrial Fibrillation Thermographic and Endoscopic Monitoring of Patients: Safety Algorithm For the Esophagus (AF TEMP-SAFE)

Trial Purpose and Description

The goal of this study is to collect data from a prospective cohort of patients undergoing standard of care catheter ablation of Atrial Fibrillation (AF) using a novel FDA-approved high resolution temperature monitoring catheter to assess esophageal temperature dynamics. The longer term goal is to establish a more rational approach to the management of esophageal temperature during catheter ablation in the heart. IND EXEMPT

Ages: 18 - 80 years

Gender: Both


Eligibility Criteria

Inclusion Criteria:

  • Subjects who meet all of the following criteria may be given consideration for inclusion in this clinical investigation, provided no exclusion criteria are met. · Subjects must be 18 > Age < 80 years · Subjects have been diagnosed with AF and be scheduled for catheter ablation. · Subjects must have a treatment plan that contemplates RFA energy application in the posterior left atrium, and/or pulmonary veins. · Subjects must be determined to be suitable candidates for ablation by their cardiologist and/or electrophysiologist. · Subjects must be ablated with the use of a Biosense Webster CARTO™. · Subjects must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements. · Subjects must understand and agree to study requirements and sign a written informed consent Exclusion: · Subjects with GFR < 30 · INR > 4.0 at the time of the procedure · Subject is pregnant women or intends to become pregnant during study participation · Have any of the following heart conditions with 90 days prior to enrollment: · New York Heart Association (NYHA) Class IV · Known unstable angina or ongoing myocardial ischemia · Congenital structural heart disease that increases the risk of ablation or precludes catheter placement · Have had a coronary intervention, cardiac surgery, or other cardiac ablation within 90 days prior to enrollment · Contraindication to anticoagulation therapy · Confirmed cardiac thrombus within 30 days prior to enrollment · History of severe esophageal ulcers, strictures, esophagitis or prior esophageal surgery · History of esophageal diverticulum or other esophageal structural abnormality. · Prior surgical or catheter ablation procedure for atrial fibrillation (does not exclude atrial flutter ablation) · Any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness, end stage COPD) · Mental impairment precluding signing consent or completing follow up · Women who are pregnant or plan to become pregnant within the course of their participation in the study · Subject is actively participating in any other investigational drug or device study
  • Subjects who have any of the following known criteria will be excluded from this clinical study.

Yale University School of Medicine

Dates: 12/01/2016 - 12/31/2017

Last Updated: 12/04/2016

Study HIC#: 2000020007

Get Involved

For more information about this study, contact:
Bemen Habashi
+1 203-737-1330
bemen.habashi@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

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Investigators

Joseph G. Akar

Principal Investigator

Sub-Investigators