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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: esolution catheter

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • OSU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Group; Placement of a luminal esophageal temperature probe (LET) and insertion of esolution esophageal retractor. In the intervention group, esolution will be utilized to deviate the esophagus during RF catheter ablation	Device: esolution catheter; esolution is a catheter-based therapy designed to displace the esophagus away from the source of ablation energy during ablation of AF and to eliminate the risk of esophageal injury
No Intervention: Control Group; Placement of a luminal esophageal temperature probe (LET) during RF ablation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: S4 Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: EASY AF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes