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

• ClinicalTrials.gov Identifier: NCT04659213
• Recruitment Status: Completed
• First Posted: December 9, 2020
• Last Update Posted: October 31, 2022
• Sponsor: S4 Medical
• Information provided by (Responsible Party): S4 Medical

Tracking Information

• First Submitted Date: December 2, 2020
• First Posted Date: December 9, 2020
• Last Update Posted Date: October 31, 2022
• Actual Study Start Date: September 1, 2021
• Actual Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 13, 2021)

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

Original Primary Outcome Measures (submitted: December 2, 2020)

Incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy [ Time Frame: 24-72 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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Brief Summary: To assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Atrial Fibrillation

Intervention

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

Study Arms

• 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
  Intervention: Device: esolution catheter
• No Intervention: Control Group
  Placement of a luminal esophageal temperature probe (LET) during RF ablation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 28, 2022): 129
• Original Estimated Enrollment (submitted: December 2, 2020): 250
• Actual Study Completion Date: July 31, 2022
• Actual Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04659213
• Other Study ID Numbers: EASY AF
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: S4 Medical
• Original Responsible Party: Same as current
• Current Study Sponsor: S4 Medical
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: S4 Medical
• Verification Date: October 2022