Actively Recruiting
Agilis Radiofrequency Transseptal System Early Feasibility Study for Cardiac Arrhythmias and Left Atrial Appendage Closure
Led by Abbott Medical Devices · Updated on 2026-06-02
60
Participants Needed
3
Research Sites
9 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Agilis Radiofrequency (RF) Transseptal System to study its initial safety and performance in crossing the atrial septum for accessing the left atrium and left ventricle during cardiac electrophysiology and interventional cardiology procedures. This early feasibility study involves a first-in-human, acute setting without long-term follow-up visits. The research aims to assess both safety and procedure success during hospital stay. Participants will undergo a transseptal procedure using the Agilis RF TSP System, which employs a radiofrequency wire to cross the atrial septum. The study focuses on an acute procedure setting with monitoring through hospital discharge, with no additional follow-up visits required. The procedure intends to facilitate access for left atrial and left ventricular interventions. During the study, participants will be observed from the time of device insertion through discharge from the hospital. Researchers will measure the rate of serious adverse events related to the device or procedure and the success rate of transseptal access as determined by the physician. The total participation time covers the procedure and hospital stay, with safety monitored periprocedurally.
CONDITIONS
Brief Title
Agilis RF TSP Early Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent before any study procedure
- Planning to have an ablation procedure in the left atrium, left ventricle, or a combined procedure with ablation and left atrial appendage closure requiring transseptal puncture
- At least 18 years old
- Able and willing to follow all study requirements
You will not qualify if you...
- Currently participating or participated within 30 days in another clinical trial that could interfere without sponsor approval
- Pregnant or nursing
- Known intracardiac thrombus
- Known circumferential pericardial effusion greater than 2 mm
- Previous interatrial septal patch or prosthetic atrial septal defect closure device
- Any thromboembolic event within the last 6 months
- Known or suspected left atrial myxoma
- Known or suspected myocardial infarction within the last 2 weeks
- Unstable angina
- Recent cerebral vascular accident within the last 3 months
- Active infection
- Unable to tolerate anticoagulation therapy
- Other medical, social, or psychological conditions that may limit participation or compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day and periprocedural period until discharge
Participants undergo the transseptal procedure using the Agilis RF TSP System, where a radiofrequency wire is used for the transseptal puncture.
1 procedure visit and monitoring until discharge
Trial Site Locations
Total: 3 locations
1
Arrhythmia Research Group (St. Bernards)
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
2
California Pacific Medical Center -Van Ness Campus
San Francisco, California, United States, 94109
Actively Recruiting
3
Research Medical Center
Kansas City, Missouri, United States, 64132
Actively Recruiting
Research Team
B
Ben Gansemer, PhD
A
Amber Miller, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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