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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

esolution catheter

About this trial

This is an interventional supportive care trial for Atrial Fibrillation

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04659213

First Posted

December 2, 2020

Last Updated

October 28, 2022

Sponsor

S4 Medical

1. Study Identification

Unique Protocol Identification Number

NCT04659213

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

S4 Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

129 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Interventional Group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

esolution catheter

Intervention Description

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 Outcome Measure Information:

Title

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

Description

The primary study endpoint is the incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy

Time Frame

15-72 hours post-ablation procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

OSU

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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