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Evaluating Active Esophageal Cooling During Cardiac Ablation Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04063761
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
University of Iowa
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 (AEF). 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 or purpose of this study is to evaluate the impact on procedural efficiency of ablation procedures performed using esophageal heat transfer to cool the esophagus during left atrial RF ablation.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: esophageal cooling device (Attune Medical, Chicago, IL) Not Applicable

Detailed Description:

This study is a prospective, pilot study using the Attune Medical esophageal heat transfer device to actively cool the esophagus during RF ablation 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.

The subjects 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 Instructions for Use (IFU). The device will remain in place until the ablation procedure is completed and will be removed before extubation. Posterior left atrial wall ablation using standard parameters will only be performed when the esophageal heat transfer device has reached a temperature of 4-6 degrees C for at least 2 minutes. The device will be set to neutral or warming temperature (37-42 degrees C) during other aspects of the procedure (such as mapping and anterior wall ablations).

All patients will be followed up in total for 6 weeks (Long Term Follow-up 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: Evaluating Active Esophageal Cooling During Cardiac Ablation Procedures
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Esophageal Cooling
Single arm study: Patients receive the Attune Medical Esophageal Heat Transfer Device
Device: esophageal cooling device (Attune Medical, Chicago, IL)
Prospective, single center pilot study




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 radiofrequency energy ]
    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 radiofrequency energy ]
    Number of procedural pauses 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 first left atrial ablation for the treatment of atrial fibrillation (AF) including pulmonary vein isolation
  • Undergoing catheter-based ablation procedure using radiofrequency energy
  • 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.
  • History of prior atrial fibrillation (AF) ablation procedures.
  • 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): NCT04063761


Contacts
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Contact: Alexander Mazur, MD 319-384-9829 alexander-mazur@uiowa.edu
Contact: Electrophysiology Research Office 319-384-1627

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Alexander Mazur, MD    319-384-9829    alexander-mazur@uiowa.edu   
Contact: Electrophysiology Research Office    319-384-1627      
Principal Investigator: Alexander Mazur, MD         
Sponsors and Collaborators
Advanced Cooling Therapy, LLC
University of Iowa
Investigators
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Principal Investigator: Alexander Mazur, MD University of Iowa

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Responsible Party: Advanced Cooling Therapy, LLC
ClinicalTrials.gov Identifier: NCT04063761     History of Changes
Other Study ID Numbers: AMEVAB2019
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 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