Clinical trial NCT04063761: Evaluating Active Esophageal Cooling During Cardiac Ablation Procedures
Official title: Evaluating Active Esophageal Cooling During Cardiac Ablation Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Advanced Cooling Therapy LLC, d/b/a Attune Medical
Sponsor class: INDUSTRY
Collaborators: name: University of Iowa
First posted: 2019-08-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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 (AEF). 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 or purpose of this study is to evaluate the impact on procedural efficiency of ablation procedures performed using esophageal heat transfer to cool the esophagus during left atrial RF ablation.

Detailed description: This study is a prospective, pilot study using the Attune Medical esophageal heat transfer device to actively cool the esophagus during RF ablation 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.

The subjects 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 Instructions for Use (IFU). The device will remain in place until the ablation procedure is completed and will be removed before extubation. Posterior left atrial wall ablation using standard parameters will only be performed when the esophageal heat transfer device has reached a temperature of 4-6 degrees C for at least 2 minutes. The device will be set to neutral or warming temperature (37-42 degrees C) during other aspects of the procedure (such as mapping and anterior wall ablations).

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

Eligibility criteria: Inclusion Criteria:

* Adult patients (age over 18 years)
* Undergoing first left atrial ablation for the treatment of atrial fibrillation (AF) including pulmonary vein isolation
* Undergoing catheter-based ablation procedure using radiofrequency energy
* 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.
* History of prior atrial fibrillation (AF) ablation procedures.
* Significant co-morbidities that preclude standard ablation procedure.
* Patients with \<40 kg of body mass
* Patients with relevant esophageal pathology (e.g. esophageal cancer)

Primary outcomes:
measure: Total Time of Active Ablation Procedure
timeFrame: Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours
Secondary outcomes:
measure: Total Procedure Time
timeFrame: Study Day 1 for all patients enrolled from patient entry to Electrophysiology (EP) lab until post procedure discharge to Post-Anesthesia Care Unit (PACU)
measure: Number of Procedural Pauses During Left Atrial Instrumentation
timeFrame: Study Day 1 for all patients enrolled, during left atrial ablation procedures using radiofrequency energy, up to 5 hours
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Alexander Mazur, MD
role: PRINCIPAL_INVESTIGATOR
References: