RecruitingNot ApplicableNCT07271238

Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures

Sponsor

LUMA Vision Ltd.

Enrollment

50 participants

Start Date

Mar 3, 2026

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Atrial Flutter Atrial Arrhythmia

Summary

The objective of the study is to collect data on the usability and integration of the VERAFEYE Imaging and Guidance System in adult patients indicated to undergo a standard of care catheter-based ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF). Results from this study may be used to guide development and refinement the VERAFEYE Imaging and Guidance System capabilities.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new imaging and navigation system called VERAFEYE that is designed to help doctors more precisely guide catheters during heart ablation procedures used to treat abnormal heart rhythms like atrial fibrillation (AFib) or atrial flutter. **You may be eligible if...** - You are 18 or older - You are already scheduled for a standard catheter ablation to treat atrial fibrillation or atrial flutter - Your doctor has recommended ablation based on current guidelines - You are able to give informed consent **You may NOT be eligible if...** - You have a contraindication to catheter ablation - You have a known blood clot in the heart - You have had a prior ablation with significant complications - You are pregnant - You are unable to tolerate the procedure for other medical reasons Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVERAFEYE Imaging and Guidance System

The VERAFEYE Imaging and Guidance System will be used during standard of care, catheter-based treatments for atrial flutter and/or atrial fibrillation.