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Clinical Trial

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

NCT: NCT07820631 · NOT_YET_RECRUITING

NCT IDNCT07820631
StatusNOT_YET_RECRUITING
Start Date2026-08-17
Completion2026-10-31
SponsorCircle Safe, Inc. (INDUSTRY)
First posted
Last updated

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 occur during the study? There is no comparison group. All participants will undergo their planned pulmonary vein ablation while the Circle Safe System is used during treatment of the right pulmonary veins. Participants will: * Complete standard assessments before the procedure * Have the Circle Safe catheter placed in the superior vena cava during the ablation procedure * Have their phrenic nerve stimulated and their diaphragm response monitored using the Circle Safe System * Be evaluated for device-related and procedure-related safety events through hospital discharge

Frequently Asked Questions

What is First-in-Human Study of the Circle Safe System for Diaphragm Response Monitoring During Pulmonary Vein Ablation?

First-in-Human Study of the Circle Safe System for Diaphragm Response Monitoring During Pulmonary Vein Ablation is a clinical trial registered under NCT07820631. Current status: NOT_YET_RECRUITING.

What is the status of NCT07820631?

The current status of NCT07820631 (First-in-Human Study of the Circle Safe System for Diaphragm Response Monitoring During Pulmonary Vein Ablation) is: NOT_YET_RECRUITING.

When did First-in-Human Study of the Circle Safe System for Diaphragm Response Monitoring During Pulmonary Vein Ablation start?

First-in-Human Study of the Circle Safe System for Diaphragm Response Monitoring During Pulmonary Vein Ablation started on 2026-08-17.

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Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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