Anatomical Navigation for Guided Electrophysiology in AFL and AFib
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 use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).
The study will collect specific information on management of AFL/AF ablation procedures with the commercial VERAFEYE Anatomical Guidance System including but not limited to acute procedural success , and how the VERAFEYE Anatomical Guidance System is used overall. Results from this study may be used to guide development and refinement the VERAFEYE Anatomical Guidance System.
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 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: 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.
Trial design
Design model
Single group
Treatments tested in this trial
VERAFEYE Anatomic Guidance System
DeviceThe VERAFEYE Anatomical 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
Acute procedural success rates during the index procedure
A procedure will be defined as successful if all the following conditions occur during the case: * Ability to create a 3D anatomical model of RA and/or LA with the VERAFEYE Imaging and Guidance System and * Ability to complete all necessary ablation lesion sets using the 3D anatomical model of RA and/or LA created with the VERAFEYE System
Time frame
During the procedureSponsors and contacts
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Source ClinicalTrials.gov