CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
EnsoETM +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/NCT03481023
NCT03481023N/ACompleted

Esophageal Cooling in Radiofrequency Cardiac Ablation: Pilot Study

Riverside Medical Center·interventional·Posted Mar 29, 2018·Updated Feb 28, 2024

In Brief

A clinical study evaluating EnsoETM and Conventional Care for Atrial Fibrillation. Completed, enrolled 6 participants across 1 site.

Detailed Summary

This pilot study evaluates the addition of the EnsoETM esophageal cooling device to the radiofrequency (RF) ablation procedure in the treatment of atrial fibrillation in adults. Half of participants will receive the EnsoETM in addition to RF ablation, while the other half will receive luminal esophageal temperature (LET) monitoring during RF ablation.

Study Details

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

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 29, 2018
Enrollment StartMar 16, 2018
Primary CompletionNov 20, 2018
Study CompletionDec 20, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.3 years ago

Interventions

EnsoETMdevice

Use of esophageal thermal regulation device during radiofrequency ablation.

Conventional Careprocedure

Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure.