Feasibility Study on the VERAFEYE System (LUMINIzE)

LUMA Vision

Status: Completed

Conditions: Atrial Fibrillation; Left Atrial Appendage Closure; Atrial Arrhythmia; Atrial Septal Defect

Treatments: Device: VERAFEYE System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05931835

LUMINIzE-P001

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Catheter-ablation and closure procedures arm

Experimental group

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

Treatment:

Device: VERAFEYE System