Registry on Luma Vision's VERAFEYE System (ENLIgHT)

Launched by LUMA VISION LTD. · Feb 27, 2024

Keywords

ClinConnect Summary

The ENLIgHT clinical trial is studying the use of a new imaging and navigation system called the VERAFEYE System during procedures for atrial fibrillation (AF) and left atrial appendage closure (LAAC). This trial aims to gather real-world information on how well this system works in helping doctors perform these procedures safely and effectively. It is not yet recruiting participants, but when it does, it will include adults aged 18 and older who are scheduled for either an AF ablation or LAAC procedure.

To participate, you need to be able to provide informed consent, meaning you understand the study and agree to take part. You should also be willing to complete all study assessments at an approved medical center. However, certain people will not be eligible, such as those who have had prior heart procedures for the same issues, pregnant women, or those currently involved in other clinical studies. If you qualify and choose to join, you can expect to contribute to important research that could help improve care for people with these heart conditions.

Gender

ALL

Eligibility 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)