Early Feasibility Study of the Agilis Radiofrequency Transseptal System for Heart Procedures

What this Trial Is About

Researchers are evaluating the Agilis Radiofrequency RF Transseptal System to study its initial safety and performance in crossing the atrial septum for accessing the left atrium and left ventricle during cardiac electrophysiology and interventional cardiology procedures. This early feasibility study involves a first-in-human, acute setting without long-term follow-up visits. The research aims to assess both safety and procedure success during hospital stay. Participants will undergo a transseptal procedure using the Agilis RF TSP System, which employs a radiofrequency wire to cross the atrial septum. The study focuses on an acute procedure setting with monitoring through hospital discharge, with no additional follow-up visits required. The procedure intends to facilitate access for left atrial and left ventricular interventions. During the study, participants will be observed from the time of device insertion through discharge from the hospital. Researchers will measure the rate of serious adverse events related to the device or procedure and the success rate of transseptal access as determined by the physician. The total participation time covers the procedure and hospital stay, with safety monitored periprocedurally.

Agilis RF TSP Early Feasibility Study