ViewFlex X ICE First-in-Human Study
NCT06772493 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2026-03-19
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).
Conditions
Interventions
- DEVICE
-
ViewFlex X ICE System
Subjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Principal Investigators
-
Kristin Ruffner, PhD · Abbott
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-16
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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