Anatomical Navigation for Guided Electrophysiology in AFL and AFib
NCT ID: NCT07210151
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2026-01-29
2026-10-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Atrial Fibrillation and Atrial Flutter arm
Subjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter and/or atrial fibrillation
VERAFEYE 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.
Interventions
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VERAFEYE 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.
Eligibility Criteria
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Inclusion Criteria
* IC2: Subject is scheduled to undergo a catheter-ablation procedure to treat AFL/AF (\*according to current international and local guidelines and per physician discretion)
* IC3: Subject is able to understand and willing to provide written informed consent
* IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site
Exclusion Criteria
* EC2: Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)
* EC3: Unrecovered/unresolved Adverse Events from any previous invasive procedure
* EC4: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure.
* EC5: Life expectancy less than 12 months
* EC6: Current LA thrombus
Note: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening per physician discretion. If an atrial thrombus is observed prior to or during the planned index procedure, the index procedure will not begin or will be terminated before accessing the left atrium, and no ablation will be performed. The index procedure for this subject may be rescheduled to be performed within 30 days post ICF signature, provided that the thrombus is no longer present.
18 Years
ALL
No
Sponsors
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LUMA Vision Ltd.
INDUSTRY
Responsible Party
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Locations
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Na Homolce Hospital
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ANGEL-AF -P004
Identifier Type: -
Identifier Source: org_study_id
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