Registry on Luma Vision's VERAFEYE System (ENLIgHT)

NCT06293430 | Not Yet Recruiting FDA Device

• 1 other identifier: ENLIgHT-P002
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Acute procedural success rates during the index 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

  During the procedure

Interventions

VERAFEYE System DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the investigator's general patient population. Subjects considered for participation in this study will be entitled to undergo a standard of care PAF ablation and/or LAAC procedure with the VERAFEYE System.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• LUMA Vision Ltd.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elke Sommerijns

CONTACT

+32479767156; elke.sommerijns@lumavision.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share