Esophageal Cooling for AF Ablation

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.

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.