Esophageal Temperature Management During Cryo AF Ablation (EnsoETM)

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Esophageal warming; Device: Control

• Registration Number: NCT04079634
• Lead Sponsor: Northwestern University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Study Start: 2019-10-08
• Primary Completion: 2021-09-30
• Study Completion: 2022-12-31
• Results First Submitted: 2023-02-23
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-24
• Last Update Submitted: 2023-04-24
• Results First Posted: 2023-05-16
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Patients above the age of 18 years old.
2. Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.
3. Patients must be willing to provide informed consent.

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Exclusion Criteria

1. Patients with contraindication to EGD.

2. History of prior AF ablation procedures.

3. Significant co-morbidities that preclude standard ablation procedure.

4. Patient is ineligible for EnsoETM placement due to:

   • Known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia).
   • Known ingestion of acidic or caustic poisons within the prior 24 hours.
   • Patients with <40 kg of body mass.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Esophageal warming	Placement of study device (EnsoETM) for temperature management
Control	Control	Placement of standard temperature probe

Primary Outcome Measures

Name	Time	Method
Number of Participants With Esophageal Thermal Injury	Post-Procedure Day 1	Endoscopic evidence of thermal injury

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States