Registry on Luma Vision's VERAFEYE System (ENLIgHT)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLUMA Vision Ltd.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- VERAFEYE System
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov