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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04659213
Recruitment Status : Completed
First Posted : December 9, 2020
Last Update Posted : October 31, 2022
Sponsor:
Information provided by (Responsible Party):
S4 Medical

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: esolution catheter Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes 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.
Primary Purpose: Supportive Care
Official Title: Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY
Actual Study Start Date : September 1, 2021
Actual Primary Completion Date : June 30, 2022
Actual Study Completion Date : July 31, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Device: 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
No Intervention: Control Group
Placement of a luminal esophageal temperature probe (LET) during RF ablation


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659213


Locations
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United States, Ohio
OSU
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
S4 Medical
More Information
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Responsible Party: S4 Medical
ClinicalTrials.gov Identifier: NCT04659213    
Other Study ID Numbers: EASY AF
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: October 31, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes