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Agilis RF TSP System for Cardiac Procedures

This study is testing a new device called the Agilis™ Radiofrequency (RF) Transseptal (TSP) System. This system helps doctors cross the wall between the heart's upper chambers (atrial septum) during procedures for heart rhythm problems (cardiac arrhythmias) or to close off a part of the heart called the left atrial appendage. The main goals are to see how safe the Agilis RF TSP System is and how well it helps doctors access the heart. You may be able to join if you are at least 18 years old, need a procedure that requires crossing the atrial septum, and are willing to follow study requirements. This is an early study, and the enrollment status is currently unclear.

Study design
This is an early study involving about 60 participants. It is designed to look at the safety and performance of the Agilis RF TSP System.
What's involved
You would undergo a transseptal procedure using the Agilis RF TSP System. You will be followed through hospital discharge, and no follow-up visits are required.
Compensation
Not stated in the trial record.
Follow-up
You will be followed from the time of Agilis RF Wire insertion through hospital discharge.

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NCT07361445

Agilis RF TSP Early Feasibility Study

Recruiting
NAAges 18+Interventional
Abbott Medical Devices
~60 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Transseptal procedure with Agilis RF TSP System.

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over During the procedure and periprocedurally
+1 more outcome measured

Conditions

Cardiac Arrythmias
Left Atrial Appendage Closure

Explore related trials

ArrhythmiaLeft Atrial Appendage Closure

Where it's being run

3 sites across 3 states
Arkansas1
California1
Missouri1

Who to contact

Ben Gansemer, PhD
[email protected]
+1 952-715-2719
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.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.Procedure

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