Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

To assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.

Key facts

Study ID

NCT04659213

Run by

S4 Medical

People needed

129

Starts

2021-09-01

Expected to finish

2022-07-31

Last updated by the study team

2022-10-31

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female age ≥ 22 years and < 80 years
• Clinical decision to proceed with AF ablation procedure.
• Ablation procedure to be completed with General Anesthesia
• Ablation procedure to be completed with use of radiofrequency catheter ablation

You may not qualify if…

• History of various esophageal pathology such as esophageal achalasia, varices, strictures, web, carcinoma, tumor/mass, scleroderma, Mallory-Weiss tear, Barrett's esophagitis, diverticulum, banding, laceration, perforation, balloon dilatation.
• Presence of a pH probe deployed in the esophagus
• Planned AF ablation procedure to be completed with laser energy or with cryo-energy
• Acute or uncontrolled psychiatric illness
• Unable to undergo upper endoscopy
• Enrollment in another FDA clinical trial
• Unstable medical condition(s) that precludes safely completing study protocol
• Subject is incarcerated
• Subject is pregnant
• Subject is unable to comprehend the details of the study
• The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the investigational device procedure and study-related follow up visit requirements

Where it is running

• OSU — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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