Using the VERAFEYE imaging and navigation system to guide catheter ablation for atrial arrhythmias
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
This study will try the VERAFEYE imaging and guidance system during catheter ablation in adults with atrial flutter or atrial fibrillation to see if it integrates well with standard procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | LUMA Vision Ltd. Industry-sponsored |
| Locations | 1 site (Split) |
| Trial ID | NCT07271238 on ClinicalTrials.gov |
What this trial studies
This is a single-center feasibility study that will use the VERAFEYE Imaging and Guidance System during routine catheter-based ablation procedures for atrial flutter, paroxysmal AF, or persistent AF. Adult patients already scheduled for standard-of-care ablation will have the VERAFEYE catheter used alongside the usual procedural workflow to collect data on usability and practical integration. Study staff will record how the device performs during mapping and navigation, any technical issues, and how it fits into procedure time and staff workflow. Results will be used to inform development and refinement of the VERAFEYE system.
Who should consider this trial
Good fit: Adults aged 18 or older who are scheduled for a standard-of-care catheter ablation for atrial flutter or atrial fibrillation and who can give informed consent and attend the study site are ideal candidates.
Not a fit: People who are pregnant, those in whom placement of the VERAFEYE catheter is not technically feasible, or those with implanted active cardiac rhythm devices are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, VERAFEYE could help physicians visualize and navigate cardiac anatomy more clearly during ablation, potentially improving procedure efficiency and safety.
How similar studies have performed: Other established cardiac imaging and navigation systems have improved ablation workflows, but VERAFEYE itself is a new system undergoing initial feasibility testing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * IC1: Subject is at least 18 years of age at the time of consent * IC2: Subject is scheduled to undergo a standard of care 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 Criteria: * 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: Subject implanted with an active cardiac rhythm management device (e.g. pacemaker, CRT, ICD) * EC4: Unrecovered/unresolved Adverse Events from any previous invasive procedure * EC5: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure * EC6: Life expectancy less than 12 months * EC7: 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. * EC8: Subjects who are currently enrolled in another study
Where this trial is running
Split
- Klinicki Bolnicki Centar (KBC) Split — Split, Croatia (Recruiting)
Study contacts
- Study coordinator: Ivan Sikiric
- Email: ivan.sikiric20@gmail.com
- Phone: +385958934912
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.