CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
Esophageal Cooling +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03691571
NCT03691571N/ACompleted
CompareCT.gov

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

University of Pennsylvania·interventional·Posted Oct 1, 2018·Updated Oct 5, 2022

In Brief

A clinical study evaluating Esophageal Cooling and Control for Atrial Fibrillation. Completed, enrolled 55 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesUnited States
CollaboratorsAttune Medical

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 1, 2018
Enrollment StartOct 11, 2018
Primary CompletionMar 25, 2020
Study CompletionFeb 28, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.8 years ago

Interventions

Esophageal Coolingdevice

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.

Controldevice

Standard of care involves standard temperature probe monitoring.