Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06293430

Registry on Luma Vision's VERAFEYE System (ENLIgHT)

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VERAFEYE System

Device

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

Primary outcomes

  1. Acute procedural success rates during the index procedure

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Elke Sommerijns

CONTACT

[email protected]

+32479767156

Sponsors and collaborators

Lead sponsor

LUMA Vision Ltd.

Industry

Registry information

Official study title

Registry on Luma Vision's VERAFEYE System in Catheter Ablation and Left Atrial Appendage Closure Procedures

Acronym: ENLIgHT

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.