Esophageal Cooling in Radiofrequency Cardiac Ablation

Esophageal Cooling in Radiofrequency Cardiac Ablation: Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: EnsoETM; Procedure: Conventional Care

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Kankakee, Illinois, United States, 60901
      • Riverside Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: LET monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esophageal Mucosal Damage	Esophageal mucosal damage as assessed by endoscopic evaluation using Zagar's Modified Endoscopic Classification Scheme. Higher scores on this scale indicate a worse outcome. The grading system is as follows: Grade 0: Normal Examination; Grade 1: Edema and Hypermia of the Mucosa; Grade 2a: Superficial ulceration, erosions, friability, blisters, exudates, hemorrhages, whitish membranes; Grade 2b: Grade 2a pluse deep discrete or circumferential ulcerations; Grade 3a: Small scattered areas of multiple ulceration and areas of necrosis with brown-black or greyish discoloration; Grade 3b: Extensive necrosis. For this grading scale we used the following scoring: 0=0 1=1 2a=2 2b=3 3a=4 3b=5	The post-intervention outcome measure was performed within 1 day after Pulmonary Vein Isolation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percentage of Participants With Treatment-Emergent Adverse Events [Safety and Adverse Events]		3 months
Presence of Esophageal Submucosal Damage, Indicated by Number of Ulcers as Assessed by Endoscopic Ultrasound (EUS)	Altered submucosal tissue architecture as assessed by endoscopic ultrasound (EUS)	1 day

Collaborators and Investigators

• Sponsor: Riverside Medical Center
• Collaborators: Attune Medical

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): November 20, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Arrhythmia; Radiofrequency Ablation; Esophageal Cooling Device
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: RMC # 186

Drug and device information, study documents

• 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