NCT04079634

Esophageal Temperature Management During Cryo AF Ablation (EnsoETM)

Esophageal Temperature Management During Cryo AF Ablation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot study is to determine if esophageal warming using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the frequency or severity of thermal injury during cryoballoon ablation of atrial fibrillation.

Detailed description

Catheter ablation of atrial fibrillation (AF) has become a common ablation procedure performed worldwide. The cornerstone of this procedure is pulmonary vein isolation (PVI). PVI can be achieved by multiple methods, the two most common being radiofrequency (RF) and cryoablation. Energy delivery may extend beyond the atrial myocardium and result in damage to adjacent structures, including the esophagus. Atrio-esophageal fistula (AEF) is a rare, but a well-recognized complication of percutaneous AF ablation. The occurrence rate of esophageal injury has varied depending on the reporting center, timing of endoscopy, and the ablation technique utilized. Esophageal ulceration is likely the initial injury that leads to AEF formation and is probably present within hours to days of the ablation procedure. The Attune Medical Esophageal Heat Transfer Device (EnsoETM) is a non-sterile, multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage. For this study, the EnsoETM tube will be used during cardiac ablation procedures for the intended indication of patient temperature management using approved settings/parameters as detailed in the product instructions for use document. EnsoETM is an FDA approved device. This prospective, randomized study will include 40 patients with symptomatic AF undergoing index PVI under general anesthesia at Northwestern Memorial Hospital. Patients will be randomized in a 1:1 fashion with 20 patients (Group A) randomized to undergo the ablation procedure with esophageal warming and the other 20 patients (Group B) will serve as the control group and will not have the EnsoETM device used. All patients will undergo esophagogastroduodenoscopy (EGD) 1-2 days following the ablation procedure to evaluate for esophageal injury.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Esophageal warming	Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure
DEVICE	Control	Standard temperature probe monitoring

Timeline

• Start date: 2019-10-08
• Primary completion: 2021-09-30
• Completion: 2022-12-31
• First posted: 2019-09-06
• Last updated: 2023-05-16
• Results posted: 2023-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study