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NCT06293430
Registry on Luma Vision's VERAFEYE System (ENLIgHT)
Conditions: Atrial Fibrillation, Left Atrial Appendage Closure, Atrial Arrhythmia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 50
Sponsor: LUMA Vision Ltd.
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.
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)
Source: ClinicalTrials.gov (NCT06293430). StuddyBuddy aggregates publicly available trial information.