Actively Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Led by LUMA Vision Ltd. · Updated on 2026-05-07
50
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is at least 18 years of age at the time of consent
- Subject is scheduled to undergo a catheter-ablation procedure to treat atrial flutter or atrial fibrillation according to guidelines and physician discretion
- Subject is able to understand and willing to provide written informed consent
- Subject is able and willing to complete all study assessments at an approved clinical study site
You will not qualify if you...
- Placement of VERAFEYE Imaging Catheter is not technically feasible as determined by physician
- Pregnant women or women planning to become pregnant during the study (must be of non-childbearing potential or have a negative pregnancy test within 7 days before procedure)
- Unrecovered or unresolved adverse events from any previous invasive procedure
- Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure
- Life expectancy less than 12 months
- Current left atrial thrombus detected within 48 hours before or during the procedure
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Na Homolce Hospital
Prague, Czechia, 150 30
Actively Recruiting
Research Team
A
Alisa Komleva
CONTACT
E
Elke Sommerijns
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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