Feasibility Study on the VERAFEYE System (LUMINIzE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation; Atrial Septal Defect; Left Atrial Appendage Closure; Atrial Arrhythmia
• Intervention / Treatment: Device: VERAFEYE System

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elke Sommerijns, MSc; Phone Number: +32479767156; Email: elke.sommerijns@lumavision.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: LUMA Vision Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Arrhythmias, Cardiac; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects; Atrial Fibrillation; Heart Septal Defects, Atrial
• Other Study ID Numbers: P001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No