Clinical trial NCT04659213: 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
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: S4 Medical
Sponsor class: INDUSTRY
First posted: 2020-12-09
Enrollment: 129
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: Incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy
timeFrame: 15-72 hours post-ablation procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OSU
state: Ohio
Study officials:
References: