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Agilis RF TSP Early Feasibility Study
Sponsor: Abbott Medical Devices
Summary
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.
Official title: Agilis Radiofrequency Transseptal System Early Feasibility Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-02-16
Completion Date
2026-08-03
Last Updated
2026-03-11
Healthy Volunteers
No
Interventions
Transseptal procedure with Agilis RF TSP System.
Radiofrequency wire will be used for the transseptal procedure.
Locations (2)
Arrhythmia Research Group (St. Bernards)
Jonesboro, Arkansas, United States
California Pacific Medical Center -Van Ness Campus
San Francisco, California, United States