Feasibility Study on the VERAFEYE System

NCT ID: NCT05931835

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-09
• Study Completion Date: 2025-05-22

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Catheter-ablation and closure procedures arm

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

Group Type: EXPERIMENTAL

VERAFEYE System

Intervention Type: 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.

Interventions

VERAFEYE System

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.

Intervention Type: DEVICE

Eligibility Criteria

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

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LUMA Vision Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mater Private Network

Dublin, Leinster, Ireland

Countries

Ireland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LUMINIzE-P001

Identifier Type: -

Identifier Source: org_study_id