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Feasibility Study on the VERAFEYE System (LUMINIzE)

Primary Purpose

Atrial Septal Defect, Atrial Fibrillation, Atrial Arrhythmia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VERAFEYE System
Sponsored by
LUMA Vision Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Septal Defect

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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) 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Catheter-ablation and closure procedures arm

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 9, 2023
    Last Updated
    October 16, 2023
    Sponsor
    LUMA Vision Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05931835
    Brief Title
    Feasibility Study on the VERAFEYE System
    Acronym
    LUMINIzE
    Official Title
    Luma Vision's Feasibility Study on the VERAFEYE System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 15, 2024 (Anticipated)
    Primary Completion Date
    April 30, 2024 (Anticipated)
    Study Completion Date
    April 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    LUMA Vision Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Septal Defect, Atrial Fibrillation, Atrial Arrhythmia, Left Atrial Appendage Closure

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Catheter-ablation and closure procedures arm
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    VERAFEYE System
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Physician Feedback on VERAFEYE System
    Description
    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.
    Time Frame
    During the procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elke Sommerijns, MSc
    Phone
    +32479767156
    Email
    elke.sommerijns@lumavision.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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