Esophageal Cooling for AF Ablation (eCoolAF)

University of Pennsylvania

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Control; Device: Esophageal Cooling

Study type: Interventional

Funder types: Other

Identifiers

NCT03691571

831401

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

55 participants in 2 patient groups

Esophageal Cooling

Experimental group

Description:

Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device).

Treatment:

Device: Esophageal Cooling

Control

Active Comparator group

Description:

Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).

Treatment:

Device: Control