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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.

Tracking Information
First Submitted Date  ICMJE June 9, 2023
First Posted Date  ICMJE July 5, 2023
Last Update Posted Date May 8, 2024
Estimated Study Start Date  ICMJE August 15, 2024
Estimated Primary Completion Date October 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2023)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2023)		 Physician Feedback on VERAFEYE Imaging System [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study on the VERAFEYE System
Official Title  ICMJE Luma Vision's Feasibility Study on the VERAFEYE System
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Atrial Septal Defect
  • Atrial Fibrillation
  • Atrial Arrhythmia
  • Left Atrial Appendage Closure
Intervention  ICMJE 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.
Study Arms  ICMJE 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
Intervention: Device: VERAFEYE System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2023)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2024
Estimated Primary Completion Date October 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elke Sommerijns, MSc +32479767156 elke.sommerijns@lumavision.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05931835
Other Study ID Numbers  ICMJE P001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party LUMA Vision Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE LUMA Vision Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account LUMA Vision Ltd.
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP