Registry on Luma Vision's VERAFEYE System (ENLIgHT)

Not yet recruiting

• Conditions: Atrial Fibrillation; Left Atrial Appendage Closure; Atrial Arrhythmia

• Registration Number: NCT06293430
• Lead Sponsor: LUMA Vision Ltd.

Brief Summary

The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-03-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Study Start: 2025-05-15
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Subject is 18 years of age or of legal age to give informed consent specific to state and national law at the time of consent
• Subjects is indicated for an atrial fibrillation ablation and/or a left atrial appendage closure procedure with the VERAFEYE System as navigation and imaging system, per physician discretion;
• Subject is able to understand and willing to provide written informed consent
• Subject is able and willing to complete all study assessments at an approved clinical investigational center

Key

Exclusion Criteria

• Subjects who have undergone a previous cardiac ablation for the treatment of PAF/LAA Closure
• Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
• Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)
• Unrecovered/unresolved Adverse Events from any previous invasive procedure
• Subjects who are currently enrolled in another study (except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute procedural success rates during the index procedure	During the procedure	A procedure will be defined as successful if all the following conditions occur during the case: * ability to create a 3D anatomical model with the VERAFEYE System and; * completion of the necessary ablation applications for PAF/LAA Closure using the 3D anatomical model created with the VERAFEYE System