An interventional study of Esophageal warming device (Attune Medical, Chicago, IL in Atrial Fibrillation, sponsored by Advanced Cooling Therapy, Inc., d/b/a Attune Medical. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-12.
Sponsored by Advanced Cooling Therapy, Inc., d/b/a Attune Medical · Not applicable, Interventional, and Prevention
Left atrial catheter ablation including pulmonary vein isolation is a standard therapy in the management of symptomatic atrial fibrillation; however thermal esophageal injury is a known potential consequence of this procedure. Delivery of radiofrequency (RF) energy necessary to perform left atrial ablation has the potential to cause injury to the nearby esophagus including ulceration, hematoma, spasm, esophageal motility disorders, and, in the most extreme case, atrial-esophageal fistula.Esophageal mucosal lesions are the likely precursor to AEF, and esophageal mucosal lesions have been detected on post-ablation endoscopy after pulmonary vein isolation with an incidence ranging from 3% to 60%.
Active esophageal cooling during RF ablation as a means of esophageal injury prevention has been investigated through mathematical models, pre-clinical studies, and in clinical trials. Existing data support the efficacy of this approach, but the practice has not been widely adopted due to lack of a commercially available device.
The aim of this study is to evaluate the impact on procedural efficiency of ablation procedures performed using esophageal heat transfer to warm the esophagus during left atrial cryoablation.
This study is a prospective, pilot study using the Attune Medical ensoETM esophageal heat transfer device to actively warm the esophagus during cryoablation procedures. This design is appropriate to gather the data needed regarding overall procedural time, compare this to historical controls, and estimate a sample size for a larger study powered for statistical significance.
Once patient consent is obtained, the subject will undergo preparation and anesthesia procedures following standard practice. Once the patient is intubated, the esophageal heat transfer device will be placed into the esophagus according to the IFU. The device will remain in place until the ablation procedure is completed and will be removed before extubation. Left atrial cryoablation using the standard approach will be performed with the ensoETM set at a temperature of 42 degrees C.
All patients will be followed up in total for 6 weeks (Long Term FU visit) after the procedure to document any clinical complication related to thermal esophageal injuries if applicable.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 20 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Advanced Cooling Therapy, Inc., d/b/a Attune Medical is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive the Attune Medical Esophageal Heat Transfer Device
Device: Esophageal warming device (Attune Medical, Chicago, IL
Prospective, single center pilot stud
Total Time of Active Ablation Procedure
Total time of active ablation procedure measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
Time frame: Study Day 1 for all patients enrolled, during left atrial ablation procedures using cryoablation
Total Procedure Time
Total procedure time from patient entry to Electrophysiology (EP) lab until discharge to Post-Anesthesia Care Unit (PACU)
Time frame: Study Day 1 for all patients enrolled from patient entry to Electrophysiology (EP) lab until post procedure discharge to Post-Anesthesia Care Unit (PACU)]
Number of Procedural Pauses During Left Atrial Instrumentation
Number of procedural pauses during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
Time frame: Study Day 1 for all patients, during left atrial ablation procedures using cryoablation
Total Duration of Fluoroscopy Use
Total duration of fluoroscopy use during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
Time frame: Study Day 1 for all patients, during left atrial ablation procedures using cryoablation
| Milestone | Esophageal Warming |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Total time of active ablation procedure measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
| minutes | Esophageal Warming |
|---|---|
| Total Time of Active Ablation Procedure | 126 (112 to 139) |
Total procedure time from patient entry to Electrophysiology (EP) lab until discharge to Post-Anesthesia Care Unit (PACU)
| minutes | Esophageal Warming |
|---|---|
| Total Procedure Time | 126 (112 to 139) |
Number of procedural pauses during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
| Procedural pauses | Esophageal Warming |
|---|---|
| Number of Procedural Pauses During Left Atrial Instrumentation | 0 (0 to 16.8) |
Total duration of fluoroscopy use during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
| minutes | Esophageal Warming |
|---|---|
| Total Duration of Fluoroscopy Use | 23.4 ± 7.8 |
Collected over 145 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Esophageal Warming | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Esophageal Warming |
|---|---|
| Mean | 68.5 ± 8.4 |
| Sex: Female, Male(Participants) | Esophageal Warming |
|---|---|
| Female | 11 |
| Male | 9 |
| Race and Ethnicity Not Collected(Participants) | Esophageal Warming |
|---|
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Advanced Cooling Therapy, Inc., d/b/a Attune Medical