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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04659213
• Other study ID #: EASY AF
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2022
• Source: S4 Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
United States	OSU	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
S4 Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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