Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VERAFEYE Imaging and Guidance System.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The objective of the study is to collect data on the usability and integration of the VERAFEYE Imaging and Guidance System in adult patients indicated to undergo a standard of care catheter-based ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF). Results from this study may be used to guide development and refinement the VERAFEYE Imaging and Guidance System capabilities.
Interventions
- Device VERAFEYE Imaging and Guidance System
The VERAFEYE Imaging and Guidance System will be used during standard of care, catheter-based treatments for atrial flutter and/or atrial fibrillation.
Primary outcome measures
- ADEs [Time frame: within 7 days of the index procedure]
- VERAFEYE Performance [Time frame: during procedure]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Croatia · 1 center
- Klinicki Bolnicki Centar (KBC) Split — Split
Identifiers
NCT: NCT07271238 · INSiGHT-P005