Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
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|ClinicalTrials.gov Identifier: NCT04087122|
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : October 2, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Esophageal warming device (Attune Medical, Chicago, IL||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures|
|Actual Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Esophageal warming
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 [ Time Frame: Study Day 1 for all patients enrolled, during left atrial ablation procedures using cryoablation ]Total time of active ablation procedure measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
- Total procedure time [ 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)] ]Total procedure time from patient entry to Electrophysiology (EP) lab until discharge to Post-Anesthesia Care Unit (PACU)
- Number of procedural pauses during left atrial instrumentation [ Time Frame: Study Day 1 for all patients, during left atrial ablation procedures using cryoablation ]Number of procedural pauses during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
- Total duration of fluoroscopy use [ Time Frame: Study Day 1 for all patients, during left atrial ablation procedures using cryoablation ]Total duration of fluoroscopy use during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087122
|Contact: Stephanie Lane, RNfirstname.lastname@example.org|
|United States, Virginia|
|Winchester Medical Center||Recruiting|
|Winchester, Virginia, United States, 22601|
|Contact: Stephanie Lane, RN 540-536-7820 email@example.com|
|Principal Investigator: Daniel Alexander, MD|
|Principal Investigator: Zachary Hollis, MD|
|Principal Investigator:||Daniel Alexander, MD||Winchester Medical Center|
|Principal Investigator:||Zachary Hollis, MD||Winchester Medical Center|