ViewFlex X ICE First-in-Human Study
Recruiting now
Conditions studied: Cardiac Arrhythmias
In brief
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).
Key facts
- Study ID
- NCT06772493
- Run by
- Abbott Medical Devices
- People needed
- 500
- Starts
- 2024-12-16
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- A patient will be eligible for clinical trial participation if they meet the following criteria:
- 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
You may not qualify if…
- A patient will be excluded from enrollment in the study if they meet any of the following criteria:
- 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
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Where it is running
- St. Bernards Medical Center — Jonesboro, Arkansas, United States (enrolling)
- University of California, San Diego — La Jolla, California, United States (enrolling)
- Ascension St. Vincent's Riverside — Jacksonville, Florida, United States (enrolling)
- Research Medical Center — Kansas City, Missouri, United States (enrolling)
- NYU Langone Health — New York, New York, United States (enrolling)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
- Houston Methodist Hospital — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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