Agilis RF TSP Early Feasibility Study

Agilis Radiofrequency Transseptal System 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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrythmias; Left Atrial Appendage Closure
• Intervention / Treatment: Device: Transseptal procedure with Agilis RF TSP System.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ben Gansemer, PhD; Phone Number: +1 952-715-2719; Email: benjamin.gansemer@abbott.com
• Study Contact Backup: Name: Amber Miller, PhD; Phone Number: 612-413-7236; Email: amber.miller@abbott.com

Study Locations

• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Recruiting
      • Arrhythmia Research Group (St. Bernards)
  • California
    • San Francisco, California, United States, 94109
      • Recruiting
      • California Pacific Medical Center -Van Ness Campus
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Recruiting
      • Research Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Is able and willing to provide written informed consent prior to any clinical investigation-related procedure
• Plans to undergo an ablation procedure in LA, LV or concomitant procedure with ablation and LAAO device implantation requiring transseptal puncture
• Is at least 18 years of age
• Able and willing to comply with all study requirements

Exclusion Criteria:

• Currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial without pre-approval from the study Sponsor
• Pregnant or nursing
• Known presence of intracardiac thrombus
• Known existing circumferential pericardial effusion (>2 mm)
• Previous interatrial septal patch or prosthetic atrial septal defect closure device
• Any previous thromboembolic event with in the last 6 months
• Known or suspected left atrial myxoma
• Known or suspected myocardial infarction within the last two weeks
• Unstable angina
• Recent (within the last 3 months) cerebral vascular accident (CVA)
• Patients with an active infection
• Patients who do not tolerate anticoagulation therapy
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transseptal Procedure	Device: Transseptal procedure with Agilis RF TSP System.; Radiofrequency wire will be used for the transseptal procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint: Rate of device and/or RF TSP procedure-related serious adverse events that occur from the time of Agilis RF Wire insertion through patient discharge.	The primary safety endpoint is the rate of device and/or RF TSP procedure-related serious adverse events that occur from the time of Agilis RF Wire insertion through patient discharge.	During the procedure and periprocedurally
Primary Effectiveness Endpoint: Rate of successful transseptal access indicated by the physician.	The primary effectiveness endpoint is the rate of successful transseptal access indicated by the physician.	Procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 3, 2026

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ABT-CIP-10601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes