Agilis RF TSP Early Feasibility Study (NCT07361445) | Clinical Trial Compass
RecruitingNot Applicable
Agilis RF TSP Early Feasibility Study
United States60 participantsStarted 2026-02-16
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 re…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: During the procedure and periprocedurally
2
Primary Effectiveness Endpoint: Rate of successful transseptal access indicated by the physician.