NCT07210151Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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 Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF). The study will collect specific information on management of AFL/AF ablation procedures with the commercial VERAFEYE Anatomical Guidance System including but not limited to acute procedural success , and how the VERAFEYE Anatomical Guidance System is used overall. Results from this study may be used to guide development and refinement the VERAFEYE Anatomical Guidance System.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 19 Sept 2025
- Start date
- 29 Jan 2026
- Primary completion date
- 16 Dec 2026
- Lead sponsor
- LUMA Vision Ltd.
- Diseases
- Atrial fibrillation
- NCT number
- NCT07210151
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 29 Jan 2026 to the primary completion date, 16 Dec 2026
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- EC4: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure.
- 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.
Other
- EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
- EC3: Unrecovered/unresolved Adverse Events from any previous invasive procedure
- EC5: Life expectancy less than 12 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Na Homolce Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| IKEM Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Klinicki Bolnicki Centar (KBC) Coordinator of this site? Confirm its status | Split | Croatia | Recruiting |
| Vilnius University Hospital Santaros Klinikos Coordinator of this site? Confirm its status | Vilnius | Lithuania | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.