Registry on Luma Vision's VERAFEYE System (ENLIgHT)

NCT ID: NCT06293430

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-10-15
• Study Completion Date: 2027-06-15

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.

Conditions

Atrial Fibrillation; Left Atrial Appendage Closure; Atrial Arrhythmia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

VERAFEYE System

VERAFEYE system guidance will be used on all patients undergoing AF ablation and/or LAAC procedures.

Intervention Type: DEVICE

Eligibility Criteria

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

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LUMA Vision Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Elke Sommerijns

Role: CONTACT

elke.sommerijns@lumavision.com

+32479767156

Other Identifiers

ENLIgHT-P002

Identifier Type: -

Identifier Source: org_study_id