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).
Study Type
OBSERVATIONAL
Enrollment
200
Subjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System
St. Bernards Medical Center
Jonesboro, Arkansas, United States
RECRUITINGUniversity of California, San Diego
La Jolla, California, United States
NOT_YET_RECRUITINGResearch Medical Center
Kansas City, Missouri, United States
Physician assessment of the ability to navigate the ViewFlex X SE catheter and adequately visualize major cardiac anatomic structures.
Time frame: During the procedure
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 procedure
Rate of device- or procedure-related serious adverse events that occur through patient discharge.
Time frame: during the procedure and periprocedurally
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NYU Langone Health
New York, New York, United States
NOT_YET_RECRUITINGMedical University of South Carolina
Charleston, South Carolina, United States
NOT_YET_RECRUITING