Actively Recruiting
Agilis RF TSP Early Feasibility Study
Led by Abbott Medical Devices · Updated on 2026-03-11
20
Participants Needed
2
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 undergo an ablation procedure in the left atrium, left ventricle, or a combined procedure with ablation and left atrial appendage occlusion device implantation requiring transseptal puncture
- At least 18 years of age
- Able and willing to follow all study requirements
You will not qualify if you...
- Currently participating in another clinical trial or participated in one within 30 days before screening without sponsor approval
- Pregnant or nursing
- Known intracardiac blood clot
- 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
- Stroke or cerebral vascular accident within the last 3 months
- Active infection
- Unable to tolerate anticoagulation therapy
- Other anatomical, medical, social, or psychological conditions that could limit participation or affect study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 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
Research Team
B
Ben Gansemer, PhD
CONTACT
A
Amber Miller, PhD
CONTACT
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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