NCT05931835Completed
Feasibility Study on the VERAFEYE System
Luma Vision's Feasibility Study on the VERAFEYE System
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 9 Jun 2023
- Start date
- 9 Jan 2025
- Primary completion date
- 15 May 2025
- Lead sponsor
- LUMA Vision Ltd.
- Diseases
- Atrial fibrillation
- NCT number
- NCT05931835
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 9 Jan 2025 to the primary completion date, 15 May 2025
- 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
- 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.
- 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)
Lab values
- 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
Other
- Body mass index (BMI) \> 40 kg/m2
- Body weight \< 50kg
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mater Private Network Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.