Esophageal Cooling in Radiofrequency Cardiac Ablation

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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 will receive the EnsoETM in addition to RF ablation, while the other half will receive luminal esophageal temperature (LET) monitoring during RF ablation.

Key facts

Study ID

NCT03481023

Run by

Riverside Medical Center

People needed

6

Starts

2018-03-16

Expected to finish

2018-12-20

Last updated by the study team

2024-02-28

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Riverside Medical Center — Kankakee, Illinois, United States

Full record on ClinicalTrials.gov

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