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
This trial does not accept healthy volunteersQualifiers
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 population
This clinical investigation will enroll subjects of all genders over the age of 18 undergoing any previously planned electrophysiology study procedure utilizing ICE.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ViewFlex X ICE System
DeviceSubjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System
Treatment groups
500 Participants
are divided into 3 treatment groupsGroup A: Cohort 11 intervention
Group B: Cohort 21 intervention
Group C: Cohort 31 intervention
Trial outcomes
Primary outcomes
1
Physician assessment of the ability to navigate the ViewFlex X SE catheter and adequately visualize major cardiac anatomic structures.
Time frame
During the procedure2
Physician assessment of the ability to use anatomic ICE markers and ICE geometry as a reference during mapping and ablation procedures.
Time frame
during the procedure3
Rate of device- or procedure-related serious adverse events that occur through patient discharge.
Time frame
during the procedure and periprocedurallySponsors and contacts
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Source ClinicalTrials.gov