An interventional study of Esophageal warming and Control in Atrial Fibrillation, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
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.
Catheter ablation of atrial fibrillation (AF) has become a common ablation procedure performed worldwide. The cornerstone of this procedure is pulmonary vein isolation (PVI). PVI can be achieved by multiple methods, the two most common being radiofrequency (RF) and cryoablation. Energy delivery may extend beyond the atrial myocardium and result in damage to adjacent structures, including the esophagus. Atrio-esophageal fistula (AEF) is a rare, but a well-recognized complication of percutaneous AF ablation. The occurrence rate of esophageal injury has varied depending on the reporting center, timing of endoscopy, and the ablation technique utilized. Esophageal ulceration is likely the initial injury that leads to AEF formation and is probably present within hours to days of the ablation procedure.
The Attune Medical Esophageal Heat Transfer Device (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. For this study, the EnsoETM tube will be used during cardiac ablation procedures for the intended indication of patient temperature management using approved settings/parameters as detailed in the product instructions for use document. EnsoETM is an FDA approved device.
This prospective, randomized study will include 40 patients with symptomatic AF undergoing index PVI under general anesthesia at Northwestern Memorial Hospital. Patients will be randomized in a 1:1 fashion with 20 patients (Group A) randomized to undergo the ablation procedure with esophageal warming and the other 20 patients (Group B) will serve as the control group and will not have the EnsoETM device used. All patients will undergo esophagogastroduodenoscopy (EGD) 1-2 days following the ablation procedure to evaluate for esophageal injury.
3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's enrollment of 42 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient is ineligible for EnsoETM placement due to:
Placement of study device (EnsoETM) for temperature management
Device: Esophageal warming
Placement of standard temperature probe
Device: Control
Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure
Standard temperature probe monitoring
Number of Participants With Esophageal Thermal Injury
Endoscopic evidence of thermal injury
Time frame: Post-Procedure Day 1
| Milestone | Treatment | Control |
|---|---|---|
| Started | 23 | 19 |
| Completed | 23 | 19 |
| Not completed | 0 | 0 |
Endoscopic evidence of thermal injury
| participants | Treatment | Control |
|---|---|---|
| Number of Participants With Esophageal Thermal Injury | 8 | 1 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Control | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Treatment | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 7 | 19 |
| >=65 years | 11 | 12 | 23 |
| Age, Continuous(years) | Treatment | Control | Total |
|---|---|---|---|
| Mean | 64.7 ± 11.0 | 66.6 ± 8.4 | 65.6 ± 9.8 |
| Sex: Female, Male(Participants) | Treatment | Control | Total |
|---|---|---|---|
| Female | 9 | 3 | 12 |
| Male | 14 | 16 | 30 |
| Race and Ethnicity Not Collected(Participants) | Treatment | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Treatment | Control | Total |
|---|---|---|---|
| United States | 23 | 19 | 42 |
| Hypertension (HTN)(participants) | Treatment | Control | Total |
|---|---|---|---|
| Number | 12 | 13 | 25 |
| Diabetes(participants) | Treatment | Control | Total |
|---|---|---|---|
| Number | 2 | 1 | 3 |
| Coronary Artery Disease (CAD)(participants) | Treatment | Control | Total |
|---|---|---|---|
| Number | 2 | 1 | 3 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes
Supporting information: Icf
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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