Anatomical Navigation for Guided Electrophysiology in AFL and AFib

NCT07210151 | Recruiting

• 1 other identifier: ANGEL-AF -P004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Flutter; Atrial Arrhythmia; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

  During the procedure

Study Arms (1)

Atrial Fibrillation and Atrial Flutter arm

EXPERIMENTAL

Subjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter and/or atrial fibrillation

Device: VERAFEYE Anatomic Guidance System

Interventions

VERAFEYE Anatomic Guidance System DEVICE

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

Atrial Fibrillation and Atrial Flutter arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LUMA Vision Ltd.: lead

Study Sites (1)

Na Homolce Hospital

Prague, 150 30, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alisa Komleva

CONTACT

0894352047; alisa.komleva@lumavision.com

Elke Sommerijns

CONTACT

+32 479 76 71 56; Elke.sommerijns@lumavision.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 7, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CZ (1)