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ViewFlex X ICE First-in-Human Study
Sponsor: 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).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2024-12-16
Completion Date
2026-06
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
ViewFlex X ICE System
Subjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System
Locations (7)
St. Bernards Medical Center
Jonesboro, Arkansas, United States
University of California, San Diego
La Jolla, California, United States
Research Medical Center
Kansas City, Missouri, United States
NYU Langone Health
New York, New York, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Houston Methodist Hospital
Houston, Texas, United States