RecruitingNot ApplicableNCT07210151

Anatomical Navigation for Guided Electrophysiology in AFL and AFib

Sponsor

LUMA Vision Ltd.

Enrollment

50 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Atrial Flutter Atrial Arrhythmia

Summary

The objective of the study is to collect data on the use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF). The study will collect specific information on management of AFL/AF ablation procedures with the commercial VERAFEYE Anatomical Guidance System including but not limited to acute procedural success , and how the VERAFEYE Anatomical Guidance System is used overall. Results from this study may be used to guide development and refinement the VERAFEYE Anatomical Guidance System.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new imaging catheter system (VERAFEYE) that creates real-time 3D maps of the heart's anatomy to guide catheter ablation procedures — a treatment for abnormal heart rhythms including atrial flutter (AFL) and atrial fibrillation (AFib). **You may be eligible if...** - You are 18 or older - You are scheduled for catheter ablation for atrial flutter or atrial fibrillation (as recommended by your doctor) - You can provide written informed consent and attend all study visits **You may NOT be eligible if...** - Your anatomy makes it technically not feasible to place the imaging catheter (as determined by your doctor) - You are pregnant or planning to become pregnant during the study - You have other conditions that make ablation unsafe 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 Anatomic Guidance System

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