Feasibility Study on the VERAFEYE System

NCT05931835 | Completed Results

• 1 other identifier: LUMINIzE-P001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Septal Defect; Atrial Fibrillation; Atrial Arrhythmia; Left Atrial Appendage Closure

Outcome Measures

Primary Outcomes (1)

• 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.

  During the procedure (up to two hours)

Study Arms (1)

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

Device: VERAFEYE System

Interventions

VERAFEYE System DEVICE

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.

Catheter-ablation and closure procedures arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LUMA Vision Ltd.: lead

Study Sites (1)

Mater Private Network

Dublin, Leinster, D07 RD8P, Ireland

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Elke Sommerijns, Director of Clinical and Medical Affairs
• Organization: LUMA Vision

elke.sommerijns@lumavision.com

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Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: July 5, 2023
• Study Start: January 9, 2025
• Primary Completion: May 15, 2025
• Study Completion: May 22, 2025
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)