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N/A N=20 Prevention

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

Atrial Fibrillation

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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

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