NCT07361445

Agilis RF TSP Early Feasibility Study

Agilis Radiofrequency Transseptal System Early Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Arrythmias
• Left Atrial Appendage Closure

Interventions

Type	Name	Description
DEVICE	Transseptal procedure with Agilis RF TSP System.	Radiofrequency wire will be used for the transseptal procedure.

Timeline

• Start date: 2026-02-16
• Primary completion: 2026-06-01
• Completion: 2026-08-03
• First posted: 2026-01-23
• Last updated: 2026-03-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study