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
500
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
RECRUITINGAscension St. Vincent's Riverside
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Jacksonville, Florida, United States
Research Medical Center
Kansas City, Missouri, United States
RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGHospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGMedical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGHouston Methodist Hospital
Houston, Texas, United States
RECRUITING