Evaluating the VERAFEYE System for heart procedures

Luma Vision's Feasibility Study on the VERAFEYE System

This study is testing a new system called VERAFEYE to see if it can improve heart procedures for people with atrial septal defects and atrial fibrillation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: LUMA Vision Ltd. (industry)
• Locations: 1 site (Dublin, Leinster)
• Trial ID: NCT05931835 on ClinicalTrials.gov

What this trial studies

This study aims to assess the performance of the VERAFEYE System in patients scheduled for standard catheter-ablation or closure procedures related to atrial septal defects and atrial fibrillation. Participants will undergo these procedures while using the VERAFEYE System, which is intended to enhance the effectiveness of the interventions. The results will inform the future development and refinement of the system, although the study does not focus on safety or efficacy endpoints.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who are scheduled for a catheter-ablation procedure or left atrial appendage closure.

Not a fit: Patients with recent significant cardiac events or surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this could lead to improved outcomes for patients undergoing heart procedures by enhancing the tools used during their treatment.

How similar studies have performed: While this approach is innovative, it is not designed for product approval, and similar studies have not been reported to show success with this specific system.

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

Where this trial is running

Dublin, Leinster

• Mater Private Network — Dublin, Leinster, Ireland (RECRUITING)

Study contacts

• Study coordinator: Alisa Komleva, BSc

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