Utility of Esophageal Cooling Therapy for the Prevention of Thermal Injury During Atrial Fibrillation Ablation: an investigator initiated randomized blinded single center pilot study

  • STATUS
    Recruiting
  • participants needed
    40
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Updated on 19 February 2024

Summary

This is a small scale pilot study to evaluate if esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the frequency or severity of thermal injury during catheter ablation of atrial fibrillation. This prospective, randomized study will include 40 patients with symptomatic AF undergoing index PVI at the Hospital of the University of Pennsylvania. Patients will be randomized in a 1:1 fashion with 20 patients (Group A) randomized to undergo the ablation procedure with esophageal cooling and the other 20 patients (Group B) will serve as the control group and will not have the EnsoETM device used. Patients randomized to Group A will have the EnsoETM device placed in the electrophysiology laboratory following intubation and prior to the ablation procedure. All patients will undergo oesophagogastroduodenoscopy (EGD) 1-2 days following the ablation procedure.

Details
Condition Atrial Fibrillation
Age 99years or below
Clinical Study Identifier03691571
Last Modified on19 February 2024

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