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OpenTrials
Completed

NCT Number: NCT04659213

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OSU

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

esolution catheter

Device

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

Primary outcomes

  1. Incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

S4 Medical

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 9, 2020
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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