Status:
COMPLETED
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
Lead Sponsor:
Advanced Cooling Therapy, Inc., d/b/a Attune Medical
Collaborating Sponsors:
Winchester Medical Center
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 ensoETM esophageal heat transfer device to actively warm the esophagus during cryoablation procedures. This design is appropriate to g...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04087122
Start Date
September 30 2019
End Date
December 31 2020
Last Update
May 12 2022
Active Locations (1)
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1
Winchester Medical Center
Winchester, Virginia, United States, 22601