Status:
NOT_YET_RECRUITING
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Lead Sponsor:
LUMA Vision Ltd.
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of the study is to collect data on the use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flu...
Eligibility Criteria
Inclusion
- IC1: Subject is at least 18 years of age at the time of consent
- IC2: Subject is scheduled to undergo a catheter-ablation procedure to treat AFL/AF (\*according to current international and local guidelines and per physician discretion)
- IC3: Subject is able to understand and willing to provide written informed consent
- IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site
Exclusion
- EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
- EC2: 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)
- EC3: Unrecovered/unresolved Adverse Events from any previous invasive procedure
- EC4: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure.
- EC5: Life expectancy less than 12 months
- EC6: Current LA thrombus
- Note: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening per physician discretion. If an atrial thrombus is observed prior to or during the planned index procedure, the index procedure will not begin or will be terminated before accessing the left atrium, and no ablation will be performed. The index procedure for this subject may be rescheduled to be performed within 30 days post ICF signature, provided that the thrombus is no longer present.
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07210151
Start Date
February 1 2026
End Date
October 1 2026
Last Update
December 8 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.