Anatomical navigation to guide catheter ablation for atrial fibrillation and flutter

Anatomical Navigation for Guided Electrophysiology in AFL and AFib

This trial will test whether the VERAFEYE Anatomical Guidance System helps doctors guide catheter ablation in adults with atrial fibrillation or atrial flutter.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: LUMA Vision Ltd. (Industry-sponsored)
• Locations: 1 site (Prague)
• Trial ID: NCT07210151 on ClinicalTrials.gov

What this trial studies

Adults scheduled for catheter ablation for atrial flutter, paroxysmal AF, or persistent AF will undergo their planned procedure using the commercial VERAFEYE Anatomical Guidance System. Clinical teams will use the device during mapping and ablation while study staff collect procedural data on how the system is used and immediate procedural outcomes. Data collected will include technical feasibility of catheter placement, acute procedural success metrics, and any procedure-related adverse events. Results will be used to inform refinement and further development of the VERAFEYE system.

Who should consider this trial

Good fit: Adults (age 18+) who are scheduled to undergo catheter ablation for atrial flutter or atrial fibrillation and who can provide informed consent and complete study assessments.

Not a fit: Patients for whom placement of the VERAFEYE imaging catheter is technically not feasible, pregnant women, or those with unresolved adverse events from prior procedures are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the system could make mapping and ablation more accurate and efficient, potentially shortening procedures and improving acute success rates.

How similar studies have performed: Other anatomical mapping and intracardiac imaging systems have demonstrated benefit in guiding ablation and reducing fluoroscopy exposure, though VERAFEYE itself is being further characterized in this study.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where this trial is running

Prague

• Na Homolce Hospital — Prague, Czechia (Recruiting)

Study contacts

• Study coordinator: Alisa Komleva

Conditions Atrial Fibrillation; Atrial Flutter; Atrial Arrhythmia