Actively Recruiting
Anatomical Navigation for Guided Electrophysiology in Atrial Flutter and Atrial Fibrillation
Led by LUMA Vision Ltd. · Updated on 2026-05-07
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of the VERAFEYE Anatomical Guidance System in adults undergoing catheter ablation procedures to treat Atrial Flutter (AFL), paroxysmal Atrial Fibrillation (PAF), or persistent Atrial Fibrillation (perAF). The study aims to collect detailed information on how this system is used during these procedures and its impact on acute procedural success, which may help refine the device's development. The study involves patients scheduled for catheter-based ablation treatments for typical atrial flutter and/or atrial fibrillation. The VERAFEYE Anatomical Guidance System will be used during these standard care procedures to guide the ablation. This is an interventional study without masking or placebo control. The treatment uses the commercial device as part of the procedure. Participants will undergo their planned ablation procedure while data on procedural success and device use are collected. Screening includes checks for eligibility such as age, ability to consent, and specific medical conditions like left atrial thrombus. Researchers will monitor outcomes during the procedure itself. The overall participation involves the treatment visit and any assessments necessary to evaluate the device's use and procedural success.
CONDITIONS
Brief 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 per physician discretion
- Pregnant women or women planning to become pregnant during the study (must have non-childbearing potential or a negative pregnancy test within 7 days before the 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
- Presence of left atrial thrombus detected within 48 hours prior to or during the procedure, which prevents or stops the ablation procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of the procedure
Participants undergo catheter-based ablation treatment for atrial flutter and/or atrial fibrillation using the VERAFEYE Anatomical Guidance System during standard of care.
1 procedure visit (in-person)
Trial Site Locations
Total: 1 location
1
Na Homolce Hospital
Prague, Czechia, 150 30
Actively Recruiting
Research Team
A
Alisa Komleva
E
Elke Sommerijns
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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