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

Not Applicable

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT04659213
• Lead Sponsor: S4 Medical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-09
• Study Start: 2021-09-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy	15-72 hours post-ablation procedure	The primary study endpoint is the incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy

Trial Locations

Locations (1)

OSU; 🇺🇸 Columbus, Ohio, United States