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

NCT04659213 | Completed FDA Device

• 1 other identifier: EASY AF
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Interventional Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Placement of a luminal esophageal temperature probe (LET) during RF ablation

Interventions

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

Interventional Group

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• S4 Medical: lead

Study Sites (1)

OSU

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study subjects will not know which treatment arm they were randomized to. Additionally, the gastroenterologist performing the endoscopy post-procedure will also be blinded to the treatment arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, multicenter, randomized controlled, double blinded clinical study to assess a reduction of esophageal lesions attributable to radiofrequency (RF) ablation with use of esolution (esophageal retractor) in comparison to conventional therapy (no use of an esophageal retractor). The randomization is with a 1:1 randomization scheme assigning consecutive patients who meet inclusion and exclusion criteria to either: placement of a luminal esophageal temperature probe(LET) (control group); or, to placement of a LET and insertion of esolution esophageal retractor (intervention group). In the control group, there will not be deviation of the esophagus and in the intervention group, esolution will be utilized to deviate the esophagus during RF catheter ablation. All randomized subjects will be included in the intent-to-treat population, which will be used in the primary study analysis.

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 9, 2020
• Study Start: September 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

US (1)