Esophageal Cooling for AF Ablation

University of Pennsylvania55 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Atrial Fibrillation

Interventions

Esophageal CoolingDEVICE

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.

ControlDEVICE

Standard of care involves standard temperature probe monitoring.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 able to understand and critically review the informed consent form. Exclusion Criteria: 1. Patients whom are unable to provide informed consent. 2. Patients with contraindication to EGD. 3. History of prior AF ablation procedures. 4. Significant co-morbidities that preclude standard ablation procedure. 5. 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.

Locations (1)

University of Pennsylvania - Perelman Center

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Number and Percentage of Participants With Esophageal Thermal Injury

Any injury, occurrence rate measured by EGD

Time frame: Day 1 to 2

Number and Percentage of Participants With Esophageal Injury Based on Severity

The severity of injury measured by EGD

Time frame: Day 1 to 2

Secondary Outcomes

Posterior Wall Ablation Parameters: Temperature

Catheter Temperature

Time frame: Day 0

Posterior Wall Ablation Parameters

Impedance drop (absolute difference)

Time frame: Day 0

Occurrence of Acute PV Reconnection

Number of Participants with Acute PV Reconnection

Time frame: Day 0

Data from ClinicalTrials.gov

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