ViewFlex X ICE First-in-Human Study
Abbott Medical Devices
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: A patient will be eligible for clinical trial participation if they meet the following criteria: 1. Able and willing to provide written informed consent prior to any clinical investigation-related procedure. 2. Plans to undergo any EP procedure utilizing ICE 3. At least 18 years of age Exclusion Criteria: A patient will be excluded from enrollment in the study if they meet any of the following criteria: 1. 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 enroll…
Interventions
- DeviceViewFlex X ICE System
Subjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System
Locations (7)
- St. Bernards Medical CenterJonesboro, Arkansas
- University of California, San DiegoLa Jolla, California
- Research Medical CenterKansas City, Missouri
- NYU Langone HealthNew York, New York
- Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania
- Medical University of South CarolinaCharleston, South Carolina