Registry on Luma Vision's VERAFEYE System (ENLIgHT)

LUMA Vision

Status: Begins enrollment in 8 months

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

Treatments: Device: VERAFEYE System

Study type: Observational

Funder types: Industry

Identifiers

NCT06293430

ENLIgHT-P002

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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)