Atrial Septal DefectLUMINIzENCT05931835

Feasibility Study on the VERAFEYE System

A study testing VERAFEYE System in people with Atrial Septal Defect and Atrial Fibrillation, run by LUMA Vision Ltd. at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure. Results from this study will be used to guide development and refinement the VERAFEYE System. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Atrial Septal Defect, Atrial Fibrillation, Atrial Arrhythmia
What is being tested?: VERAFEYE System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteIreland
Study dates: 9 Jan 2025to 22 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is 18 to 80 years of age at the time of consent
Subject is scheduled to undergo a standard of care, de-novo catheter-ablation procedure to treat typical AFL or AF; or left atrial appendage (LAA)/ atrial septal defect (ASD) closure procedure
Subject is able to understand and willing to provide written informed consent

Who cannot join

Any of the following within 6 months prior to enrolment:
Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
Thromboembolic event (stroke), transient ischemic attack (TIA) or neurological disturbances
Myocardial infarction
Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
Dilated or hypertropic cardiomyopathy

Show all 19Show fewer

Any planned surgical or endovascular intervention within 30 days before or after the ablation, or LAA/ASD closure procedure.
Any of the following cardiac conditions:
New York Heart Association (NYHA) class IV
Left ventricular ejection fraction (LVEF) < 30%
Implanted with a cardiac rhythm management device (pacemaker, CRT, ICD, loop recorder)
Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
Active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
Body mass index (BMI) > 40 kg/m2
Body weight < 50kg
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 ablation, or LAA/ASD closure procedure)
Life expectancy less than 12 months
Subjects who are currently enrolled in another study
Subjects with a thrombus or pericardial effusion detected in the LA/LAA during standard of care imaging

Trial locations and contacts

1 site in 1 country.

Ireland1 site

Mater Private Network
Dublin, Leinster, D07 RD8P

Other trials in Ireland

About this study

Official title: Luma Vision's Feasibility Study on the VERAFEYE System

The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure.

Results from this study will be used to guide development and refinement the VERAFEYE System. The study is not designed to collect data for product approval and as such does not have a safety or efficacy endpoint.

Conditions: Atrial Septal Defect, Atrial Fibrillation, Atrial Arrhythmia, Left Atrial Appendage Closure
Being tested: VERAFEYE System
Medical subject headings: Heart Septal Defects, Atrial, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VERAFEYE SystemDevice
The VERAFEYE System will be used during standard of care, catheter-based treatments for atrial flutter or atrial fibrillation; or left atrial appendage/atrial septal defect closure procedures.

Study groups in NCT05931835
Study group	Role	What they receive
Catheter-ablation and closure procedures arm	Experimental	Subjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter or atrial fibrillation and subjects entitled to undergo a left atrial appendage/atrial septal defect closure procedure Receives: Device: VERAFEYE System

What is being measured

The primary outcome is the main question the study is designed to answer.

Physician Feedback on VERAFEYE System
The objective of the study is to collect physician feedback by means of a questionnaire on the VERAFEYE System. Results from this study may be used to guide development and refinement of the VERAFEYE System.
Measured: During the procedure (up to two hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jan 202522 May 2025

First posted5 Jul 2023
Study start9 Jan 2025
Primary completion15 May 2025
Study completion22 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial Septal DefectStudies 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: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05931835
Sponsor's protocol ID: LUMINIzE-P001
Acronym: LUMINIzE
Status last verified: Feb 2026
First submitted: 9 Jun 2023
Last updated: 10 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Atrial Septal Defect trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Luma Vision's Feasibility Study on the VERAFEYE System
ClinicalTrials.gov ID: NCT05931835
Acronym / sponsor ID: LUMINIzE / LUMINIzE-P001
Conditions: Atrial Septal Defect, Atrial Fibrillation, Atrial Arrhythmia, Left Atrial Appendage Closure
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: LUMA Vision Ltd.Industry (pharma, biotech, devices)
Study start: 9 Jan 2025 (actual)
Primary completion: 15 May 2025 (actual)
Study completion: 22 May 2025 (actual)
First posted: 5 Jul 2023 (actual)
Results: Posted 10 Feb 2026

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 evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Catheter-ablation and closure procedures arm	Experimental	Device: VERAFEYE SystemSubjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter or atrial fibrillation and subjects entitled to undergo a left atrial appendage/atrial septal defect closure procedure

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subject is 18 to 80 years of age at the time of consent
Subject is scheduled to undergo a standard of care, de-novo catheter-ablation procedure to treat typical AFL or AF; or left atrial appendage (LAA)/ atrial septal defect (ASD) closure procedure
Subject is able to understand and willing to provide written informed consent

Key exclusion criteria (19 listed)

Any of the following within 6 months prior to enrolment:
Any planned surgical or endovascular intervention within 30 days before or after the ablation, or LAA/ASD closure procedure.
Any of the following cardiac conditions:
Body mass index (BMI) > 40 kg/m2
Body weight < 50kg

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 SystemThe VERAFEYE System will be used during standard of care, catheter-based treatments for atrial flutter or atrial fibrillation; or left atrial appendage/atrial septal defect closure procedures.	Device	Catheter-ablation and closure procedures arm

Primary outcome

Physician Feedback on VERAFEYE System
Time frame: During the procedure (up to two hours)
The objective of the study is to collect physician feedback by means of a questionnaire on the VERAFEYE System. Results from this study may be used to guide development and refinement of the VERAFEYE System.

Results and safety

Results posted to the registry on 10 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Catheter-ablation Arm	18	18

Primary outcome: Physician Feedback on VERAFEYE System

Time frame: During the procedure (up to two hours). Number. Unit: percentage of participants

Measure	Catheter-ablation Arm n = 17
VERAFEYE Imaging Catheter (VIC) rated as able to navigate to RA	100
Introduction of the VIC into the vasculature&navigation to the RA rated as acceptable and above	100
Visualization of major anatomical structures (excl. LA) from the RA rated as acceptable and above	100
Visualization of the LA from the RA rated acceptable and above	100
Articulation/maneuverability of the VIC rated acceptable and above	100
Ability of the System to visualize the third party devices rated acceptable and above	100
Overall image quality 2D rated acceptable and above	94.1
Overall image quality 4D rated acceptable and above	88.2

Adverse events

Time frame: 7 days post index procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Catheter-ablation Arm	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Limitations and caveats (from the sponsor): LUMINIzE was designed as a single-center feasibility study without safety/effectiveness endpoints since the study was intended to collect data for future R\&D development. High volume ablating center with experienced Investigators was selected for participation in this study. Therefore, the procedural data reported in this clinical study may be different in other settings as it is expected that operator experience can positively influence the outcomes of the procedures.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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 System in people with Atrial Septal Defect and Atrial Fibrillation, run by LUMA Vision Ltd. at 1 site in Ireland.

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 3 inclusion and 19 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: finished, as of the sponsor's last update on 10 Feb 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 Ireland. 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?

Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physician Feedback on VERAFEYE System (time frame: During the procedure (up to two hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05931835.

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 10 Feb 2026.