A Multicenter Feasibility Study With the VERAFEYE Imaging and Guidance System as Anatomical Navigation System
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorLUMA Vision Ltd.
About this trial
PRISM: A Multicenter Feasibility Study with the VERAFEYE Imaging and Guidance System as Anatomical Navigation System
Eligibility criteria
Qualifiers
IC1: Subject is at least 22 years of age at the time of consent, or older as required by local law
IC2: Subject has documented PAF/perAF
IC3: Subject is scheduled to undergo a catheter-ablation procedure to treat PAF/perAF with a commercially-approved and VIS-compatible ablation system
IC4: Subject is able to understand and willing to provide written informed consent
Disqualifiers
a. Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotom
b. Thromboembolic event (stroke), transient ischemic attack (TIA) or neurological disturbance
c. Myocardial infarction
d. Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
Trial design
Treatments tested in this trial
- Catheter Ablation
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov