CompletedNot Applicable

Feasibility Study on the VERAFEYE System

Ireland18 participantsStarted 2025-01-09

Plain-language 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. The study is not designed to collect data for product approval and as such does not have a safety or efficacy endpoint.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * 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: * 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 * 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 wome…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Physician Feedback on VERAFEYE System

Timeframe: During the procedure (up to two hours)

Trial details

NCT IDNCT05931835

SponsorLUMA Vision Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-15

Results submitted2025-12-01

View on ClinicalTrials.gov More Atrial Septal Defect trials