Atrial FibrillationANGEL-AFNCT07210151
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
A study testing VERAFEYE Anatomic Guidance System in people with Atrial Fibrillation and Atrial Flutter, run by LUMA Vision Ltd. at 4 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmia
- What is being tested?
- VERAFEYE Anatomic Guidance System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 29 Jan 2026to 16 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IC1: Subject is at least 18 years of age at the time of consent
- 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
Who cannot join
- EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
- 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.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Czechia2 sites, 2 recruiting
- Recruiting
Na Homolce Hospital
Prague, 150 30
Marko Tichy, marko.tichy@homolka.cz
- Not yet recruiting
IKEM
Prague
Ivana Kuklova, +420733677694, ivana.kuklova@ikem.cz
Josef Kautzner, Prof
Croatia1 site, 1 recruiting
- Recruiting
Klinicki Bolnicki Centar (KBC)
Split, 21000
Ivan Aranza, +385 91 794 7452, aranza.ivan@gmail.com
Lithuania1 site, 1 recruiting
- Not yet recruiting
Vilnius University Hospital Santaros klinikos
Vilnius
Kristina Scerbakovaite, +37065626747
Gediminas Rackauskas, MD
About this study
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
- Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmia
- Being tested
- VERAFEYE Anatomic Guidance System
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VERAFEYE Anatomic Guidance SystemDevice
The VERAFEYE Anatomical Guidance System will be used during standard of care, catheter-based treatments for atrial flutter and/or atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation and Atrial Flutter arm | Experimental | Subjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter and/or atrial fibrillation Receives: Device: VERAFEYE Anatomic Guidance System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute procedural success rates during the index procedure
A procedure will be defined as successful if all the following conditions occur during the case:
- Ability to create a 3D anatomical model of RA and/or LA with the VERAFEYE Imaging and Guidance System and
- Ability to complete all necessary ablation lesion sets using the 3D anatomical model of RA and/or LA created with the VERAFEYE System
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start29 Jan 2026
- Primary completion16 Dec 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LUMA Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210151
- Sponsor's protocol ID
- ANGEL-AF -P004
- Acronym
- ANGEL-AF
- Status last verified
- Nov 2026
- First submitted
- 19 Sep 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Navigation for Guided Electrophysiology in AFL and AFib
- ClinicalTrials.gov ID
- NCT07210151
- Acronym / sponsor ID
- ANGEL-AF / ANGEL-AF -P004
- Conditions
- Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- LUMA Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 16 Dec 2026 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation and Atrial Flutter arm | Experimental | Device: VERAFEYE Anatomic Guidance SystemSubjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter and/or atrial fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- IC1: Subject is at least 18 years of age at the time of consent
- 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
Key exclusion criteria (7 listed)
- EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VERAFEYE Anatomic Guidance SystemThe VERAFEYE Anatomical Guidance System will be used during standard of care, catheter-based treatments for atrial flutter and/or atrial fibrillation. | Device | Atrial Fibrillation and Atrial Flutter arm |
Primary outcome
Acute procedural success rates during the index procedure
Time frame: During the procedure
A procedure will be defined as successful if all the following conditions occur during the case: * Ability to create a 3D anatomical model of RA and/or LA with the VERAFEYE Imaging and Guidance System and * Ability to complete all necessary ablation lesion sets using the 3D anatomical model of RA and/or LA created with the VERAFEYE System
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VERAFEYE Anatomic Guidance System in people with Atrial Fibrillation and Atrial Flutter, run by LUMA Vision Ltd. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia, Croatia, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alisa Komleva (0894352047, alisa.komleva@lumavision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute procedural success rates during the index procedure (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.