Atrial FibrillationINSiGHTNCT07271238
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
A study testing VERAFEYE Imaging and Guidance System in people with Atrial Fibrillation and Atrial Flutter, run by LUMA Vision Ltd. at 1 site in Croatia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmia
- What is being tested?
- VERAFEYE Imaging and Guidance System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- 3 Mar 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
Klinicki Bolnicki Centar (KBC) Split
Split, 21000
Ivan Sikiric, +385958934912, ivan.sikiric20@gmail.com
Ante Anic
About this study
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.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmia
- Being tested
- VERAFEYE Imaging and Guidance System
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VERAFEYE Imaging and Guidance SystemDevice
The VERAFEYE Imaging and Guidance System will be used during standard of care, catheter-based treatments for atrial flutter and/or atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation and Atrial Flutter arm | Experimental | Subjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter and/or atrial fibrillation Receives: Device: VERAFEYE Imaging and Guidance System |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADEs
- Rate of device-related adverse events (ADEs) occurring within 7 days of the index procedure
Measured: within 7 days of the index procedure
VERAFEYE Performance
- Ability of VERAFEYE Imaging and Guidance System to:
- Visualize major cardiac structures (e.g. RA, septum, LA, PVs)
- Create 3D anatomical model with the VERAFEYE Imaging and Guidance System
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start3 Mar 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LUMA Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271238
- Sponsor's protocol ID
- INSiGHT-P005
- Acronym
- INSiGHT
- Status last verified
- Sep 2026
- First submitted
- 27 Nov 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
- ClinicalTrials.gov ID
- NCT07271238
- Acronym / sponsor ID
- INSiGHT / INSiGHT-P005
- Conditions
- Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- LUMA Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation and Atrial Flutter arm | Experimental | Device: VERAFEYE Imaging and Guidance SystemSubjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter and/or atrial fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VERAFEYE Imaging and Guidance SystemThe VERAFEYE Imaging and Guidance System will be used during standard of care, catheter-based treatments for atrial flutter and/or atrial fibrillation. | Device | Atrial Fibrillation and Atrial Flutter arm |
Primary outcome
ADEs
Time frame: within 7 days of the index procedure
• Rate of device-related adverse events (ADEs) occurring within 7 days of the index procedure
VERAFEYE Performance
Time frame: during procedure
• Ability of VERAFEYE Imaging and Guidance System to: * Visualize major cardiac structures (e.g. RA, septum, LA, PVs) * Create 3D anatomical model with the VERAFEYE Imaging and Guidance System
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
Related trials for Atrial Fibrillation
Enrolling by invitationObservational study
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
Cardiovascular Diseases, Arrhythmias, Cardiac
Recruiting
Posterior Mitral Isthmus Line With Vein of Marshall Ethanolisation Compared With Anterior Mitral Lines in Patients With Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
Not yet recruiting
Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study
Atrial Fibrillation (AF), Pulmonary Embolism (PE)
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
RecruitingObservational study
Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation
Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VERAFEYE Imaging and Guidance System in people with Atrial Fibrillation and Atrial Flutter, run by LUMA Vision Ltd. at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivan Sikiric (+385958934912, ivan.sikiric20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADEs (time frame: within 7 days of the index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.