Anatomical navigation to guide catheter ablation for atrial fibrillation and flutter

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Klinicki Bolnicki Centar (KBC)
  Split, Croatia Recruiting
• Na Homolce Hospital
  Prague, Czechia Recruiting
• Ikem
  Prague, Czechia Not yet recruiting
• Vilnius University Hospital Santaros klinikos
  Vilnius, Lithuania Not yet recruiting

Study contacts

• Study coordinator: Alisa Komleva
• Email: alisa.komleva@lumavision.com
• Phone: 0894352047

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.