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RecruitingNot ApplicableNCT07361445

Agilis RF TSP Early Feasibility Study

Agilis Radiofrequency Transseptal System Early Feasibility Study

Sponsor

Abbott Medical Devices

Enrollment

60 participants

Start Date

Feb 16, 2026

Study Type

INTERVENTIONAL

Conditions

Left Atrial Appendage ClosureCardiac Arrythmias

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Transseptal procedure with Agilis RF TSP System. for people with cardiac arrythmias and left atrial appendage closure. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETransseptal procedure with Agilis RF TSP System.

Radiofrequency wire will be used for the transseptal procedure.

Locations(3)

Arrhythmia Research Group (St. Bernards)

Jonesboro, Arkansas, United States

California Pacific Medical Center -Van Ness Campus

San Francisco, California, United States

Research Medical Center

Kansas City, Missouri, United States

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NCT07361445

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