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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
VERAFEYE System
DeviceVERAFEYE system guidance will be used on all patients undergoing AF ablation and/or LAAC procedures.
Treatment groups
No treatment groups listed
Trial outcomes
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
Time frame
During the procedureLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: