Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLUMA Vision Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
VERAFEYE Imaging and Guidance System
DeviceThe VERAFEYE Imaging and Guidance System will be used during standard of care, catheter-based treatments for atrial flutter and/or atrial fibrillation.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Atrial Fibrillation and Atrial Flutter armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ADEs
• Rate of device-related adverse events (ADEs) occurring within 7 days of the index procedure
Time frame
within 7 days of the index procedure2
VERAFEYE Performance
• Ability of VERAFEYE Imaging and Guidance System to: * Visualize major cardiac structures (e.g. RA, septum, LA, PVs) * Create 3D anatomical model with the VERAFEYE Imaging and Guidance System
Time frame
during procedureSponsors and contacts
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Source ClinicalTrials.gov