NCT07271238Recruiting
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
The objective of the study is to collect data on the usability and integration of the VERAFEYE Imaging and Guidance System in adult patients indicated to undergo a standard of care catheter-based ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF). Results from this study may be used to guide development and refinement the VERAFEYE Imaging and Guidance System capabilities.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 27 Nov 2025
- Start date
- 3 Mar 2026
- Primary completion date
- 15 Dec 2026
- Lead sponsor
- LUMA Vision Ltd.
- Diseases
- Atrial fibrillation
- NCT number
- NCT07271238
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 3 Mar 2026 to the primary completion date, 15 Dec 2026
- 1 site in 1 country
- 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)
- EC5: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure
- 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.
Other illness
- EC3: Subject implanted with an active cardiac rhythm management device (e.g. pacemaker, CRT, ICD)
Other
- EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
- EC4: Unrecovered/unresolved Adverse Events from any previous invasive procedure
- EC6: Life expectancy less than 12 months
- EC8: Subjects who are currently enrolled in another study
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 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinicki Bolnicki Centar (KBC) Split Coordinator of this site? Confirm its status | Split | Croatia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.