Registry on Luma Vision's VERAFEYE System (ENLIgHT)

Atrial Fibrillation Clinical Trial

— ENLIgHT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06293430
• Other study ID #: P002
• Status: Not yet recruiting
• Start date: September 15, 2024
• Est. completion date: March 15, 2025

Study information

• Verified date: May 2024
• Source: LUMA Vision Ltd.
• Contact: Elke Sommerijns
• Phone: +32479767156
• Email: elke.sommerijns[@]lumavision.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Results from this study will be used to guide development of the VERAFEYE System.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 intracardiac echocardiography 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:

• Subject is contraindicated for intracardiac echocardiography (ICE) catheter placement or placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion

• Any known contraindication to intracardiac echocardiography imaging, including those listed in the system instructions for use

• Subjects with an indication for intracardiac echocardiography imaging that is not according to the system instructions for use

• 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)

• Subjects who are currently enrolled in another study that would directly interfere with this study

Related Conditions & MeSH terms

• Atrial Arrhythmia
• Atrial Fibrillation
• Left Atrial Appendage Closure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LUMA Vision Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success of procedure	Number of subjects with adequate VERAFEYE imaging representation during procedure, as assessed by the investigator; for visualization of major cardiac structures; for guiding procedural intervention; to detect/ assess intra-procedural complications	During the procedure
Primary	Procedural Complications	Number of subjects with procedure-related and/or device-related adverse events (AEs)	During the procedure