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.

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Key information

Conditions

Cardiac Arrythmias Left Atrial Appendage Closure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arrhythmia Research Group (St. Bernards), Jonesboro, Arkansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transseptal procedure with Agilis RF TSP System.

Device

Radiofrequency wire will be used for the transseptal procedure.

Primary outcomes

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.

Time frame: During the procedure and periprocedurally

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.
Primary Effectiveness Endpoint: Rate of successful transseptal access indicated by the physician.

Time frame: Procedure

The primary effectiveness endpoint is the rate of successful transseptal access indicated by the physician.

Study contacts

Contact information is provided by the study sponsor or research team.

Amber Miller, PhD

CONTACT

[email protected]

612-413-7236

Ben Gansemer, PhD

CONTACT

[email protected]

+1 952-715-2719

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Agilis Radiofrequency Transseptal System Early Feasibility Study

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jan 23, 2026
Registry last updated: Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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