Agilis RF TSP Early Feasibility Study

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.

NCT Number	NCT07361445
Lead Sponsor	Abbott Medical Devices
Conditions	Cardiac Arrythmias, Left Atrial Appendage Closure
Enrollment	60 participants
Start Date	2026-02-16
Primary Completion	2026-06-01 (estimated)
Study Completion	2026-08-03 (estimated)
Updated on ClinicalTrials.gov	2026-06-02