Status:
COMPLETED
Evaluating Active Esophageal Cooling During Cardiac Ablation Procedures
Lead Sponsor:
Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Collaborating Sponsors:
University of Iowa
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 cons...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04063761
Start Date
June 20 2019
End Date
February 20 2021
Last Update
June 17 2025
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52242