Study of a Novel Medical Device to Monitor Esophageal Luminal Temperature During Cardiac Ablation of Atrial Fibrillation — AF-02  

Atrial Fibrillation Clinical Trial

Official title: Study of a Novel Medical Device to Monitor Esophageal Luminal Temperature During Cardiac Ablation of Atrial Fibrillation

Status Not yet recruiting

Clinical Trial Summary

Esophageal temperature monitoring during certain cardiac ablation procedures, such as left cardiac ablation procedures, is an accepted and important part of many clinical procedures today. The primary risk of the temperature monitoring devices relates to performance. Inadequate temperature recording, inadequate capture of peak temperatures or slow temperature response times can lead to inadequate monitoring of the ablation procedure.

The E-SAFE Esophageal Temperature Probe (E-SAFE) is a unique combination of currently available technologies that improves the accuracy of esophageal temperature monitoring. The incremental improvements of the E-SAFE device provide accurate, precise and fast measurement of esophageal temperature during cardiac ablation procedures. Accurate esophageal temperature monitoring must be accomplished safely; therefore, the rationale of this pivotal clinical investigation is to evaluate the safety and clinical performance of the E-SAFE device in monitoring esophageal temperature during AF ablation procedures.

Esophageal temperature monitoring should be used together with all standard clinical practices for esophageal protection during cardiac ablation procedures.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT05587959
• Study type: Interventional
• Source: BioTex, Inc.
• Contact: Britnee L Ochabski
• Phone: 713-741-0111
• Email: britnee.ochabski@biotexmedical.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Completion date: July 2025