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RECRUITING
NCT07361445
NA

Agilis RF TSP Early Feasibility Study

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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

DEVICE

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