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NCT06293430 | NOT YET RECRUITING | Atrial Fibrillation

Registry on Luma Vision's VERAFEYE System (ENLIgHT)
Sponsor:

LUMA Vision Ltd.

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.

Condition or disease

Atrial Fibrillation

Left Atrial Appendage Closure

Atrial Arrhythmia

Intervention/treatment

VERAFEYE System

Study Type : OBSERVATIONAL
Estimated Enrollment : 50 participants
Official Title : Registry on Luma Vision's VERAFEYE System in Catheter Ablation and Left Atrial Appendage Closure Procedures
Actual Study Start Date : 2025-03-15
Estimated Primary Completion Date : 2025-10-15
Estimated Study Completion Date : 2025-10-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 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
  • 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)
Registry on Luma Vision's VERAFEYE System (ENLIgHT)

Location Details

NCT06293430

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How to Participate

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