Feasibility Study on the VERAFEYE System

Sponsor
LUMA Vision Ltd.
Study ID
NCT05931835
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • VERAFEYE System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 9, 2025
Status verified
Feb 2026
Primary completion
May 15, 2025
Completion
May 22, 2025

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Catheter-ablation and closure procedures arm
    Subjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter or atrial fibrillation and subjects entitled to undergo a left atrial appendage/atrial septal defect closure procedure

Primary Outcome Measure

Physician Feedback on VERAFEYE System [ Time Frame: During the procedure (up to two hours) ]

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