Esophageal Cooling for AF Ablation

Last updated: September 28, 2022
Sponsor: University of Pennsylvania
Overall Status: Completed

Phase

N/A

Condition

Cardiac Disease

Arrhythmia

Chest Pain

Treatment

N/A

Clinical Study ID

NCT03691571
831401
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients above the age of 18 years old.
  2. Patients with the diagnosis of atrial fibrillation undergoing clinically indicatedde-novo AF ablation procedure.
  3. Patients must be able to understand and critically review the informed consent form.

Exclusion

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 historyof esophagectomy, previous swallowing disorders, achalasia).
  • Known ingestion of acidic or caustic poisons within the prior 24 hours.
  • Patients with <40 kg of body mass.

Study Design

Total Participants: 55
Study Start date:
October 11, 2018
Estimated Completion Date:
February 28, 2021

Study 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.

Connect with a study center

  • University of Pennsylvania - Perelman Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.