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Feasibility Study on the VERAFEYE System (LUMINIzE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05931835
Recruitment Status : Not yet recruiting
First Posted : July 5, 2023
Last Update Posted : May 8, 2024
Sponsor:
Information provided by (Responsible Party):
LUMA Vision Ltd.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Atrial Septal Defect Atrial Fibrillation Atrial Arrhythmia Left Atrial Appendage Closure Device: VERAFEYE System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 System
Estimated Study Start Date : August 15, 2024
Estimated Primary Completion Date : October 30, 2024
Estimated Study Completion Date : October 30, 2024
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Physician Feedback on VERAFEYE System [ Time Frame: During the procedure ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05931835


Contacts
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Contact: Elke Sommerijns, MSc +32479767156 elke.sommerijns@lumavision.com

Sponsors and Collaborators
LUMA Vision Ltd.
More Information
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Responsible Party: LUMA Vision Ltd.
ClinicalTrials.gov Identifier: NCT05931835    
Other Study ID Numbers: P001
First Posted: July 5, 2023    Key Record Dates
Last Update Posted: May 8, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Heart Septal Defects, Atrial
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities