Esophageal Cooling for AF Ablation (eCoolAF)

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Esophageal Cooling; Device: Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania - Perelman Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Attune Medical

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2018
• Primary Completion (Actual): March 25, 2020
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 831401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No