Clinical Trial: First-in-Human Study of the Circle Safe System for Diaphragm Response Monitoring During Pulmonary Vein Ablation

U.S., Sept. 16 -- ClinicalTrials.gov registry received information related to the study (NCT07820631) titled 'First-in-Human Study of the Circle Safe System for Diaphragm Response Monitoring During Pulmonary Vein Ablation' on July 22.

Brief Summary: The objective of this first-in-human study is to evaluate the safety and performance of the Circle Safe System in subjects undergoing pulmonary vein ablation for atrial fibrillation.

The main questions it aims to answer are:

* Can the Circle Safe System consistently stimulate the phrenic nerve and record a stable electrical response from the diaphragm?

* Can it reliably display changes in the diaphragm's response during ablation?

* What device-related or procedure-related medical problems o...