A Multicenter Feasibility Study With the VERAFEYE Imaging and Guidance System as Anatomical Navigation System
NCT07686328 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-07-07
Summary
PRISM: A Multicenter Feasibility Study with the VERAFEYE Imaging and Guidance System as Anatomical Navigation System
Conditions
- Paroxysmal Atrial Fibrillation
- Persistent Atrial Fibrillation
Interventions
- DEVICE
-
Catheter Ablation
The study will utilize the VERAFEYE Imaging and Guidance System for real-time imaging and anatomical navigation in combination with a commercially approved and VIS-compatible ablation system. The choice of the ablation system is per physician discretion.
Sponsors & Collaborators
-
LUMA Vision Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-01
- Primary Completion
- 2027-02-01
- Completion
- 2027-02-01
- FDA Device
- Yes
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