Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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

Group Type EXPERIMENTAL

esolution catheter

Intervention Type 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

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

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

Minimum Eligible Age

22 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No