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Esophageal Cooling in Radiofrequency Cardiac Ablation

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. Identifier: NCT03481023
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Attune Medical
Information provided by (Responsible Party):
Brad Suprenant, Riverside Medical Center

Brief Summary:
This pilot study evaluates the addition of the EnsoETM esophageal cooling device to the radiofrequency (RF) ablation procedure in the treatment of atrial fibrillation in adults. Half of participants will receive the EnsoETM in addition to RF ablation, while the other half will receive luminal esophageal temperature (LET) monitoring during RF ablation.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: EnsoETM Procedure: Conventional Care Not Applicable

Detailed Description:

Study Specific Procedures:

  • Study specific imaging will include endoscopic evaluation of the esophagus one day before surgery at the time of the pre-op Transesophageal Echocardiography (TEE) and again 1-day post-op. This will include endoscopic esophageal intubation with visual assessment of the entire esophagus and grading of lesions. Coupled with this procedure will include endoscopic ultrasound assessment of the esophagus at the level of the left atrium with specific attention to the sub-mucosal layer that separates esophagus from the cardiac tissue. The patient will undergo moderate sedation during this procedure, which will accompany the TEE.
  • The Esophageal Cooling Device (ECD) will be placed by trained study staff following endotracheal intubation. Proper positioning will be verified. A temperature probe will be placed to verify the patients core temperature. The target temperature will be set to the core temperature at the beginning of the procedure. Two minutes prior to ablation on the posterior wall the target temperature will be changed to the minimum temperature setting which will allow for maximal cooling. Cooling will take place throughout the duration of posterior wall ablation. After ablation in this territory is complete the target temperature will return to the patients core temperature. The device will be removed at the completion of the procedure by anesthesiology when there is no further need for an orogastric tube.
  • LET monitoring will not be performed in the patients of the intervention group as the ECD is prohibitive. Therefore, ice lavage of the esophagus, as detailed below, will not be performed in this group.

Standard Care Procedures:

  • Medical History will be obtained by interview and will involve identification of contraindications to the use of the ECD. This includes a history of esophageal perforation or varices. An allergy to silicone will be assessed.
  • The patient's active medication list will be reviewed as is standard protocol for atrial fibrillation ablation, but this is not specific to the study as there are no medications that would impact the use of the ECD.
  • All subjects will be on Protonix (40mg; twice daily) immediately following surgery for 30 days and anticoagulation for 3 months following surgery.
  • The physical exam will be performed. Study specific exam is included as part of the airway assessment which is performed on a regular basis by anesthesiology. The oropharynx will be assessed prior to placement of the ECD.
  • Radiofrequency ablation involving the posterior aspect of the left atrium will be performed with standard LET monitoring which may include intermittent boluses of iced lavaged saline through the nasogastric tube when the temperature rises above 1 degree centigrade. Termination of atrial fibrillation with provocation testing will be completed and further atrial tachyarrhythmia ablation will be carried out as indicated.
  • The patient will follow-up in the office based on standard procedure with 10 day and 3 month follow-up to be scheduled.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will be blinded to which condition they were assigned; the Outcomes Assessor will be blinded to the hypotheses of the study as well as the condition to which the participant was assigned.
Primary Purpose: Treatment
Official Title: Esophageal Cooling in Radiofrequency Cardiac Ablation: Pilot Study
Actual Study Start Date : March 16, 2018
Estimated Primary Completion Date : August 20, 2018
Estimated Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Esophageal thermal regulation device Device: EnsoETM
Use of esophageal thermal regulation device during radiofrequency ablation.

Active Comparator: LET monitoring Procedure: Conventional Care
Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure.
Other Name: LET monitoring

Primary Outcome Measures :
  1. Esophageal Mucosal Damage [ Time Frame: 1 day ]
    Esophageal mucosal damage as assessed by endoscopic evaluation using Zagar's Modified Endoscopic Classification Scheme

Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Adverse Events] [ Time Frame: 3 months ]
    Adverse events observed after radiofrequency ablation

  2. Esophageal Submucosal Damage [ Time Frame: 1 day ]
    Altered submucosal tissue architecture as assessed by endoscopic ultrasound (EUS)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has an atrial arrhythmia requiring radiofrequency ablation on the posterior aspect of the heart.
  • Subject is willing and able to provide informed consent.
  • Subject is capable of adhering to the expectations of the study protocol (e.g., attending follow-up visit).

Exclusion Criteria:

  • Subject has known esophageal deformity, or evidence of esophageal trauma.
  • Subject has prior radiation therapy involving the esophagus.
  • Subject has a history of esophageal disease (e.g., esophageal varices, cirrhosis, history of esophagectomy, previous swallowing disorders, or achalasia).
  • Subject has ingested acidic or caustic poisons.
  • Subject is incarcerated.
  • Subject is pregnant or plans to become pregnant.
  • Subject has a silicone allergy.
  • Subject has esophageal bleeding prior to surgical procedure.

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 identifier (NCT number): NCT03481023

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Contact: Brad Suprenant, D.O. 815-939-9400
Contact: Joseph Hanks, B.S. 815-935-7256 ext 6151

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United States, Illinois
Riverside Medical Center Recruiting
Kankakee, Illinois, United States, 60901
Contact: Brad Suprenant, DO    815-939-9400   
Contact: Joseph Hanks, BS    815-935-7256 ext 6151   
Sub-Investigator: Bradley Clark, DO         
Sponsors and Collaborators
Riverside Medical Center
Attune Medical
  Study Documents (Full-Text)

Documents provided by Brad Suprenant, Riverside Medical Center:
Study Protocol  [PDF] March 20, 2018

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Responsible Party: Brad Suprenant, Principal Investigator, Riverside Medical Center Identifier: NCT03481023     History of Changes
Other Study ID Numbers: RMC # 186
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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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.: Yes

Keywords provided by Brad Suprenant, Riverside Medical Center:
Atrial Fibrillation
Esophageal Cooling Device
Radiofrequency Ablation

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes