Agilis RF TSP Early Feasibility Study
Recruiting now · Not applicable
Conditions studied: Cardiac Arrythmias, Left Atrial Appendage Closure
In brief
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.
Key facts
- Study ID
- NCT07361445
- Run by
- Abbott Medical Devices
- People needed
- 60
- Starts
- 2026-02-16
- Expected to finish
- 2026-08-03
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Arrhythmia Research Group (St. Bernards) — Jonesboro, Arkansas, United States (enrolling)
- California Pacific Medical Center -Van Ness Campus — San Francisco, California, United States (enrolling)
- Research Medical Center — Kansas City, Missouri, United States (enrolling)
Full record on ClinicalTrials.gov
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