Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures

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.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 of this study is to evaluate the impact on procedural efficiency of ablation procedures performed using esophageal heat transfer to warm the esophagus during left atrial cryoablation.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Esophageal warming device (Attune Medical, Chicago, IL

Detailed Description

This study is a prospective, pilot study using the Attune Medical ensoETM esophageal heat transfer device to actively warm the esophagus during cryoablation 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.

Once patient consent is obtained, the subject 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 IFU. The device will remain in place until the ablation procedure is completed and will be removed before extubation. Left atrial cryoablation using the standard approach will be performed with the ensoETM set at a temperature of 42 degrees C.

All patients will be followed up in total for 6 weeks (Long Term FU visit) after the procedure to document any clinical complication related to thermal esophageal injuries if applicable.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Winchester, Virginia, United States, 22601
      • Winchester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients (age over 18 years).
• Undergoing cryoablation for the treatment of atrial fibrillation, including pulmonary vein isolation.
• 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.
• Significant co-morbidities that preclude standard ablation procedure.
• Patients with <40 kg of body mass.
• Patients with relevant esophageal pathology (e.g. esophageal cancer).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Esophageal warming; Patients receive the Attune Medical Esophageal Heat Transfer Device	Device: Esophageal warming device (Attune Medical, Chicago, IL; Prospective, single center pilot stud

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Time of Active Ablation Procedure	Total time of active ablation procedure measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)	Study Day 1 for all patients enrolled, during left atrial ablation procedures using cryoablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Procedure Time	Total procedure time from patient entry to Electrophysiology (EP) lab until discharge to Post-Anesthesia Care Unit (PACU)	Study Day 1 for all patients enrolled from patient entry to Electrophysiology (EP) lab until post procedure discharge to Post-Anesthesia Care Unit (PACU)]
Number of Procedural Pauses During Left Atrial Instrumentation	Number of procedural pauses during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)	Study Day 1 for all patients, during left atrial ablation procedures using cryoablation
Total Duration of Fluoroscopy Use	Total duration of fluoroscopy use during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)	Study Day 1 for all patients, during left atrial ablation procedures using cryoablation

Collaborators and Investigators

• Sponsor: Advanced Cooling Therapy, Inc., d/b/a Attune Medical
• Collaborators: Winchester Medical Center
• Investigators: Principal Investigator: Daniel Alexander, MD, Winchester Medical Center; Principal Investigator: Zachary Hollis, MD, Winchester Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2019
• Primary Completion (ACTUAL): July 30, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (ACTUAL): September 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: WMC-Cryo

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.: No