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Esophageal Cooling for AF Ablation (eCoolAF)

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ClinicalTrials.gov Identifier: NCT03691571
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Attune Medical
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The purpose of this study is to determine if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the number or seriousness of injury to the esophagus during atrial fibrillation ablation procedures. The EnsoETM is an FDA cleared device used for temperature management, but is not routinely used during atrial fibrillation ablation procedures.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Esophageal Cooling Device: Control Not Applicable

Detailed Description:
The 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. Modulation and control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger. Two lumens connect to the external heat exchanger, while a third central lumen provides stomach access for connection to a fluid collection device with low intermittent suction for gastric decompression. The EnsoETM is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less. Distilled water circulates within the EnsoETM just like a water blanket.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, blinded single center pilot study
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation Ablation (eCoolAF)
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Esophageal Cooling
Patients randomized to Group A receive the EnsoETM (Attune Medical Esophageal Heat Transfer Device).
Device: Esophageal Cooling
The 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.
Other Names:
  • Attune Medical Esophageal Heat Transfer Device
  • EnsoETM

Active Comparator: Control
Patients randomized to Group B receive standard of care treatment (standard temperature probe monitoring).
Device: Control
Standard of care involves standard temperature probe monitoring.
Other Name: Standard of care




Primary Outcome Measures :
  1. Esophageal thermal injury between groups measured by EGD [ Time Frame: Day 1 to 2 ]
    Any injury, occurrence rate measured by EGD

  2. Esophageal injury between groups [ Time Frame: Day 1 to 2 ]
    The severity and size of injury measured by EGD


Secondary Outcome Measures :
  1. Posterior wall ablation parameters: Temperature [ Time Frame: Day 0 ]
    initial and maximum temperatures

  2. Posterior wall ablation parameters [ Time Frame: Day 0 ]
    Impedance drop (absolute difference)

  3. Occurrence of acute PV reconnection [ Time Frame: Day 0 ]
    PV reconnection present or no as recorded in Carto

  4. Location of acute PV reconnection [ Time Frame: Day 0 ]
    Location of PV reconnection present or no as recorded in Carto

  5. Freedom from AF [ Time Frame: 3 months, 6 months, and 12 months ]
    Clinically documented Atrial Fibrillation via review of multiple data sources in clinical record



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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:

  1. Patients above the age of 18 years old.
  2. Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.
  3. Patients must be able to understand and critically review the informed consent form.

Exclusion Criteria:

  1. Patients whom are unable to provide informed consent.
  2. Patients with contraindication to EGD.
  3. History of prior AF ablation procedures.
  4. Significant co-morbidities that preclude standard ablation procedure.
  5. Patient is ineligible for EnsoETM placement due to:

    • Known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia).
    • Known ingestion of acidic or caustic poisons within the prior 24 hours.
    • Patients with <40 kg of body mass.

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): NCT03691571


Contacts
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Contact: Pasquale Santangeli, MD,PhD 215-662-6005 pasquale.santangeli@uphs.upenn.edu
Contact: Cory Tschabrunn, PhD, CEPS 215-614-0482 cory.tschabrunn@uphs.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania - Perelman Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Tiffany Sharkoski, MPH, MBE    215-615-2354    tiffany.sharkoski@uphs.upenn.edu   
Principal Investigator: Pasquale Santangeli, MD, PhD         
Principal Investigator: Cory M Tschabrunn, PhD, CEPS         
Sponsors and Collaborators
University of Pennsylvania
Attune Medical

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03691571     History of Changes
Other Study ID Numbers: 831401
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 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
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