Esophageal Cooling for AF Ablation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Esophageal Cooling; Device: Control

• Registration Number: NCT03691571
• Lead Sponsor: University of Pennsylvania

Brief 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.

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 Timeline

• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-01
• Study Start: 2018-10-11
• Primary Completion: 2020-03-25
• Study Completion: 2021-02-28
• Results First Submitted: 2021-08-19
• Results First Submitted QC: 2021-11-22
• Results First Posted: 2021-12-21
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esophageal Cooling	Esophageal Cooling	Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device).
Control	Control	Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).

Primary Outcome Measures

Name	Time	Method
Number and Percentage of Participants With Esophageal Thermal Injury	Day 1 to 2	Any injury, occurrence rate measured by EGD
Number and Percentage of Participants With Esophageal Injury Based on Severity	Day 1 to 2	The severity of injury measured by EGD

Secondary Outcome Measures

Name	Time	Method
Posterior Wall Ablation Parameters: Temperature	Day 0	Catheter Temperature
Posterior Wall Ablation Parameters	Day 0	Impedance drop (absolute difference)
Occurrence of Acute PV Reconnection	Day 0	Number of Participants with Acute PV Reconnection

Trial Locations

Locations (1)

University of Pennsylvania - Perelman Center; 🇺🇸 Philadelphia, Pennsylvania, United States