Esophageal Cooling in Radiofrequency Cardiac Ablation
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EnsoETM
Conventional Care
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Esophageal Cooling Device, Radiofrequency Ablation, Arrhythmia
Eligibility Criteria
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.
Sites / Locations
- Riverside Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Esophageal thermal regulation device
LET monitoring
Arm Description
Outcomes
Primary Outcome Measures
Esophageal Mucosal Damage
Esophageal mucosal damage as assessed by endoscopic evaluation using Zagar's Modified Endoscopic Classification Scheme
Secondary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Safety and Adverse Events]
Adverse events observed after radiofrequency ablation
Esophageal Submucosal Damage
Altered submucosal tissue architecture as assessed by endoscopic ultrasound (EUS)
Full Information
NCT ID
NCT03481023
First Posted
March 20, 2018
Last Updated
March 26, 2018
Sponsor
Riverside Medical Center
Collaborators
Attune Medical
1. Study Identification
Unique Protocol Identification Number
NCT03481023
Brief Title
Esophageal Cooling in Radiofrequency Cardiac Ablation
Official Title
Esophageal Cooling in Radiofrequency Cardiac Ablation: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
August 20, 2018 (Anticipated)
Study Completion Date
December 20, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riverside Medical Center
Collaborators
Attune Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Esophageal Cooling Device, Radiofrequency Ablation, Arrhythmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Esophageal thermal regulation device
Arm Type
Experimental
Arm Title
LET monitoring
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
EnsoETM
Intervention Description
Use of esophageal thermal regulation device during radiofrequency ablation.
Intervention Type
Procedure
Intervention Name(s)
Conventional Care
Other Intervention Name(s)
LET monitoring
Intervention Description
Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure.
Primary Outcome Measure Information:
Title
Esophageal Mucosal Damage
Description
Esophageal mucosal damage as assessed by endoscopic evaluation using Zagar's Modified Endoscopic Classification Scheme
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Adverse Events]
Description
Adverse events observed after radiofrequency ablation
Time Frame
3 months
Title
Esophageal Submucosal Damage
Description
Altered submucosal tissue architecture as assessed by endoscopic ultrasound (EUS)
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brad Suprenant, D.O.
Phone
815-939-9400
Email
blsuprenant@comcast.net
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Hanks, B.S.
Phone
815-935-7256
Ext
6151
Email
jhanks@RHC.net
Facility Information:
Facility Name
Riverside Medical Center
City
Kankakee
State/Province
Illinois
ZIP/Postal Code
60901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brad Suprenant, DO
Phone
815-939-9400
Email
bsuprenant@RHC.net
First Name & Middle Initial & Last Name & Degree
Joseph Hanks, BS
Phone
815-935-7256
Ext
6151
Email
jhanks@RHC.net
First Name & Middle Initial & Last Name & Degree
Bradley Clark, DO
12. IPD Sharing Statement
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Esophageal Cooling in Radiofrequency Cardiac Ablation
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