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

S4 Medical

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: esolution catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT04659213

EASY AF

Details and patient eligibility

About

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

Enrollment: 129 patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

129 participants in 2 patient groups

Interventional Group

Experimental group

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

Treatment:

Device: esolution catheter

Control Group

No Intervention group

Description:

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