N/A
N=20
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT04087122 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Total Time of Active Ablation Procedure — 126 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Esophageal warming device (Attune Medical, Chicago, IL (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Advanced Cooling Therapy, Inc., d/b/a Attune Medical
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Time of Active Ablation Procedure |
126 | — |
| SECONDARY Total Procedure Time |
126 | — |
| SECONDARY Number of Procedural Pauses During Left Atrial Instrumentation |
— | — |
| SECONDARY Total Duration of Fluoroscopy Use |
23.4 | — |
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.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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04087122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.