Esophageal Cooling for AF Ablation

Atrial Fibrillation Clinical Trial

— eCoolAF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691571
• Other study ID #: 831401
• Status: Completed
• Phase: N/A
• Start date: October 11, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: September 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 28, 2021
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.
• Control
Standard of care involves standard temperature probe monitoring.

Locations

Country	Name	City	State
United States	University of Pennsylvania - Perelman Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Attune Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and Percentage of Participants With Esophageal Thermal Injury	Any injury, occurrence rate measured by EGD	Day 1 to 2
Primary	Number and Percentage of Participants With Esophageal Injury Based on Severity	The severity of injury measured by EGD	Day 1 to 2
Secondary	Posterior Wall Ablation Parameters: Temperature	Catheter Temperature	Day 0
Secondary	Posterior Wall Ablation Parameters	Impedance drop (absolute difference)	Day 0
Secondary	Occurrence of Acute PV Reconnection	Number of Participants with Acute PV Reconnection	Day 0