Using the VERAFEYE imaging and navigation system to guide catheter ablation for atrial arrhythmias

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

This is a single-center feasibility study that will use the VERAFEYE Imaging and Guidance System during routine catheter-based ablation procedures for atrial flutter, paroxysmal AF, or persistent AF. Adult patients already scheduled for standard-of-care ablation will have the VERAFEYE catheter used alongside the usual procedural workflow to collect data on usability and practical integration. Study staff will record how the device performs during mapping and navigation, any technical issues, and how it fits into procedure time and staff workflow. Results will be used to inform development and refinement 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 standard of care 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: Subject implanted with an active cardiac rhythm management device (e.g. pacemaker, CRT, ICD)
* EC4: Unrecovered/unresolved Adverse Events from any previous invasive procedure
* EC5: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure
* EC6: Life expectancy less than 12 months
* EC7: 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.
* EC8: Subjects who are currently enrolled in another study

Where it's running

• Klinicki Bolnicki Centar (KBC) Split
  Split, Croatia Recruiting

Study contacts

• Study coordinator: Ivan Sikiric
• Email: ivan.sikiric20@gmail.com
• Phone: +385958934912

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.