Feasibility Study on the VERAFEYE System

Atrial Fibrillation Clinical Trial

— LUMINIzE  

Official title:

Luma Vision's Feasibility Study on the VERAFEYE System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05931835
• Other study ID #: P001
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2024
• Est. completion date: October 30, 2024

Study information

• Verified date: May 2024
• Source: LUMA Vision Ltd.
• Contact: Elke Sommerijns, MSc
• Phone: +32479767156
• Email: elke.sommerijns[@]lumavision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Arrhythmia
• Atrial Fibrillation
• Atrial Septal Defect
• Heart Septal Defects, Atrial
• Left Atrial Appendage Closure

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LUMA Vision Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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