Atrial Fibrillation
Conditions
Brief summary
To assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.
Interventions
DEVICEesolution 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
Sponsors
S4 Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, 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.
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.
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy | 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 |
Countries
United States
Outcome results
None listed