At a glance
ClinicalIndex Comparison RecordN/ACompleted· 42 enrolled
Drug / intervention
Esophageal warming +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.
Esophageal Temperature Management During Cryo AF Ablation
In Brief
A clinical study evaluating Esophageal warming and Control for Atrial Fibrillation. Completed, enrolled 42 participants across 1 site.
Detailed Summary
The purpose of this pilot study is to determine if esophageal warming using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the frequency or severity of thermal injury during cryoballoon ablation of atrial fibrillation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesUnited States
CollaboratorsAttune Medical
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartOct 2019
Primary CompletionSep 2021
Study CompletionDec 2022
TodayJul 2026
First PostedSep 6, 2019
Enrollment StartOct 8, 2019
Primary CompletionSep 30, 2021
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.8 years ago
Interventions
Esophageal warmingdevice
Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure
Controldevice
Standard temperature probe monitoring