ViewFlex X ICE First-in-Human Study
ConditionCardiac Arrhythmias
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data integration with the EnSite X EP System (hereafter referred to as the ViewFlex X ICE System).
Eligibility criteria
Qualifiers
Able and willing to provide written informed consent prior to any clinical investigation-related procedure.
Plans to undergo any EP procedure utilizing ICE
At least 18 years of age
Disqualifiers
Subject is currently participating in another clinical trial with an active treatment arm or has participated in such a clinical trial within 30 days prior to enrollment that may interfere with this clinical trial without pre-approval from this study Sponsor
Implanted mechanical mitral or tricuspid valve replacement
Implanted intracardiac device within 30 days
Pregnant or nursing
Trial design
Treatments tested in this trial
- ViewFlex X ICE System
Treatment groups
500 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov