NCT05931835

Feasibility Study on the VERAFEYE System

Luma Vision's Feasibility Study on the VERAFEYE System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: LUMA Vision Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure. Results from this study will be used to guide development and refinement the VERAFEYE System. The study is not designed to collect data for product approval and as such does not have a safety or efficacy endpoint.

Conditions

• Atrial Septal Defect
• Atrial Fibrillation
• Atrial Arrhythmia
• Left Atrial Appendage Closure

Interventions

Type	Name	Description
DEVICE	VERAFEYE System	The VERAFEYE System will be used during standard of care, catheter-based treatments for atrial flutter or atrial fibrillation; or left atrial appendage/atrial septal defect closure procedures.

Timeline

• Start date: 2025-01-09
• Primary completion: 2025-05-15
• Completion: 2025-05-22
• First posted: 2023-07-05
• Last updated: 2026-02-10
• Results posted: 2026-02-10

Locations

1 site across 1 country: Ireland