Status:
COMPLETED
Esophageal Cooling in Radiofrequency Cardiac Ablation
Lead Sponsor:
Riverside Medical Center
Collaborating Sponsors:
Attune Medical
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This pilot study evaluates the addition of the EnsoETM esophageal cooling device to the radiofrequency (RF) ablation procedure in the treatment of atrial fibrillation in adults. Half of participants w...
Detailed Description
Study Specific Procedures: * Study specific imaging will include endoscopic evaluation of the esophagus one day before surgery at the time of the pre-op Transesophageal Echocardiography (TEE) and aga...
Eligibility Criteria
Inclusion
- Subject has an atrial arrhythmia requiring radiofrequency ablation on the posterior aspect of the heart.
- Subject is willing and able to provide informed consent.
- Subject is capable of adhering to the expectations of the study protocol (e.g., attending follow-up visit).
Exclusion
- Subject has known esophageal deformity, or evidence of esophageal trauma.
- Subject has prior radiation therapy involving the esophagus.
- Subject has a history of esophageal disease (e.g., esophageal varices, cirrhosis, history of esophagectomy, previous swallowing disorders, or achalasia).
- Subject has ingested acidic or caustic poisons.
- Subject is incarcerated.
- Subject is pregnant or plans to become pregnant.
- Subject has a silicone allergy.
- Subject has esophageal bleeding prior to surgical procedure.
Key Trial Info
Start Date :
March 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03481023
Start Date
March 16 2018
End Date
December 20 2018
Last Update
February 28 2024
Active Locations (1)
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1
Riverside Medical Center
Kankakee, Illinois, United States, 60901