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

Study Overview
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Brief Summary
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To assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: esolution catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Group<br>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<br>* 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<br>|
| No Intervention: Control Group<br>Placement of a luminal esophageal temperature probe (LET) during RF ablation | |

What is the study measuring?
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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 |