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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
Sponsor:
Collaborator:
Winchester Medical Center
Information provided by (Responsible Party):
Advanced Cooling Therapy, LLC

Brief Summary:

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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (age over 18 years).
  • Undergoing cryoablation for the treatment of atrial fibrillation, including pulmonary vein isolation.
  • Patients must be able to understand and critically review the informed consent form.
  • Subjects must understand and agree to study requirements and sign a written informed consent.

Exclusion Criteria:

  • Patients who are unable to provide informed consent.
  • Significant co-morbidities that preclude standard ablation procedure.
  • Patients with <40 kg of body mass.
  • Patients with relevant esophageal pathology (e.g. esophageal cancer).

Information from the National Library of Medicine

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


Contacts
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Contact: Stephanie Lane, RN 540-536-7820 slane@valleyhealthlink.com

Locations
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United States, Virginia
Winchester Medical Center Recruiting
Winchester, Virginia, United States, 22601
Contact: Stephanie Lane, RN    540-536-7820    slane@valleyhealthlink.com   
Principal Investigator: Daniel Alexander, MD         
Principal Investigator: Zachary Hollis, MD         
Sponsors and Collaborators
Advanced Cooling Therapy, LLC
Winchester Medical Center
Investigators
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Principal Investigator: Daniel Alexander, MD Winchester Medical Center
Principal Investigator: Zachary Hollis, MD Winchester Medical Center

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Responsible Party: Advanced Cooling Therapy, LLC
ClinicalTrials.gov Identifier: NCT04087122     History of Changes
Other Study ID Numbers: WMC-Cryo
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes