At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 80 years at time of consent
- ✓Scheduled for de-novo catheter-ablation for atrial flutter/fibrillation OR LAA/ASD closure procedure
- ✓Able to understand and willing to provide written informed consent
- ✕Cardiac surgery (CABG, ventriculotomy, atriotomy) within 6 months prior to enrollment
- ✕Thromboembolic event (stroke), TIA, or neurological disturbances within 6 months prior to enrollment
- ✕Myocardial infarction within 6 months prior to enrollment
- ✕Any surgical or percutaneous cardiac procedure (including coronary intervention and cardiac ablation) within 6 months prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Luma Vision's Feasibility Study on the VERAFEYE System
In Brief
A clinical study evaluating VERAFEYE System for Atrial Septal Defect and 3 related conditions. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.