LUMINIzE: Feasibility Study on the VERAFEYE Imaging System

Sponsor

LUMA Vision Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05931835

Collaborator

(none)

Enrollment

Arm

4.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The objective of the study is to evaluate the performance of the VERAFEYE Imaging 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 Imaging System. The study is not designed to collect data for product approval and as such does not have a safety or efficacy endpoint.

Condition or Disease	Intervention/Treatment	Phase
Atrial Septal Defect Patent Foramen Ovale Atrial Fibrillation Atrial Arrhythmia	Device: VERAFEYE Imaging System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Luma Vision's Feasibility Study on the VERAFEYE Imaging System

Anticipated Study Start Date :

Dec 15, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

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/patent foramen ovale closure procedure	Device: VERAFEYE Imaging System The VERAFEYE Imaging System will be used during standard of care, catheter-based treatments for atrial flutter or atrial fibrillation; or left atrial appendage/atrial septal defect/patent foramen ovale closure procedures.

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/patent foramen ovale closure procedure

Device: VERAFEYE Imaging System

The VERAFEYE Imaging System will be used during standard of care, catheter-based treatments for atrial flutter or atrial fibrillation; or left atrial appendage/atrial septal defect/patent foramen ovale closure procedures.

Outcome Measures

Primary Outcome Measures

Physician Feedback on VERAFEYE Imaging System [During the procedure]
The objective of the study is to collect physician feedback by means of a questionnaire on the VERAFEYE Imaging System. Results from this study may be used to guide development and refinement of the VERAFEYE Imaging System.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)/ patent foramen ovale (PFO) 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/PFO 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

LUMA Vision Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LUMA Vision Ltd.

ClinicalTrials.gov Identifier:

NCT05931835

Other Study ID Numbers:

P001

First Posted:

Jul 5, 2023

Last Update Posted:

Jul 5, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrial Fibrillation

Foramen Ovale, Patent

Heart Septal Defects, Atrial

Study Results

No Results Posted as of Jul 5, 2023