Esophageal Cooling for AF Ablation

Study Overview
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Brief Summary
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The purpose of this study is to determine if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the number or seriousness of injury to the esophagus during atrial fibrillation ablation procedures. The EnsoETM is an FDA cleared device used for temperature management, but is not routinely used during atrial fibrillation ablation procedures.

Detailed Description
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The 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. Modulation and control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger. Two lumens connect to the external heat exchanger, while a third central lumen provides stomach access for connection to a fluid collection device with low intermittent suction for gastric decompression. The EnsoETM is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less. Distilled water circulates within the EnsoETM just like a water blanket.

Official Title
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Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation Ablation (eCoolAF)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Esophageal Cooling
* Device: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients above the age of 18 years old. Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure. Patients must be able to understand and critically review the informed consent form. Exclusion Criteria: Patients whom are unable to provide informed consent. Patients with contraindication to EGD. History of prior AF ablation procedures. Significant co-morbidities that preclude standard ablation procedure. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, blinded single center pilot study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esophageal Cooling<br>Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device). | Device: Esophageal Cooling<br>* The 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.<br>* Other names: EnsoETM;|
| Active Comparator: Control<br>Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring). | Device: Control<br>* Standard of care involves standard temperature probe monitoring.<br>* Other names: Standard of care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Percentage of Participants With Esophageal Thermal Injury | Any injury, occurrence rate measured by EGD | Day 1 to 2 | 
| Number and Percentage of Participants With Esophageal Injury Based on Severity | The severity of injury measured by EGD | Day 1 to 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posterior Wall Ablation Parameters: Temperature | Catheter Temperature | Day 0 | 
| Posterior Wall Ablation Parameters | Impedance drop (absolute difference) | Day 0 | 
| Occurrence of Acute PV Reconnection | Number of Participants with Acute PV Reconnection | Day 0 |