This study is a prospective, acute, first-in-human, early feasibility study intended to assess the initial safety and performance of the Agilis™ Radiofrequency (RF) Transseptal (TSP) System in crossing the atrial septum for left atrial and left ventricular access during cardiac electrophysiology (EP) and interventional cardiology (IC) procedures. This study will be conducted in an acute setting. Subjects will be followed through hospital discharge, and no follow-up visits will be required for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
60
Radiofrequency wire will be used for the transseptal procedure.
Arrhythmia Research Group (St. Bernards)
Jonesboro, Arkansas, United States
RECRUITINGCalifornia Pacific Medical Center -Van Ness Campus
San Francisco, California, United States
RECRUITINGResearch Medical Center
Kansas City, Missouri, United States
RECRUITINGPrimary Safety Endpoint: Rate of device and/or RF TSP procedure-related serious adverse events that occur from the time of Agilis RF Wire insertion through patient discharge.
The primary safety endpoint is the rate of device and/or RF TSP procedure-related serious adverse events that occur from the time of Agilis RF Wire insertion through patient discharge.
Time frame: During the procedure and periprocedurally
Primary Effectiveness Endpoint: Rate of successful transseptal access indicated by the physician.
The primary effectiveness endpoint is the rate of successful transseptal access indicated by the physician.
Time frame: Procedure
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