Agilis RF system to cross the atrial septum for left heart access
Agilis Radiofrequency Transseptal System Early Feasibility Study
This will test a radiofrequency transseptal device to help adults needing left atrial or left ventricular procedures safely cross the atrial septum.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 2 sites (Jonesboro, Arkansas and 1 other locations) |
| Trial ID | NCT07361445 on ClinicalTrials.gov |
What this trial studies
This is a prospective, acute, first-in-human early feasibility study testing the Agilis RF Transseptal System to cross the atrial septum for left atrial and left ventricular access during electrophysiology and interventional cardiology procedures. The device is used during transseptal puncture in procedures such as left atrial or ventricular ablation and left atrial appendage occlusion device implantation. Subjects are treated in an acute hospital setting and monitored through hospital discharge with no scheduled post-discharge study visits. The study will record immediate procedural success and acute safety outcomes related to crossing the septum.
Who should consider this trial
Good fit: Adults (18 or older) who can give informed consent and are planning left atrial or left ventricular ablation or combined ablation with left atrial appendage occlusion that requires transseptal puncture are ideal candidates.
Not a fit: Patients who are pregnant or nursing, have intracardiac thrombus, recent thromboembolic events, recent myocardial infarction, prior septal patch or closure device, or who are clinically unstable are unlikely to be eligible or to receive benefit.
Why it matters
Potential benefit: If successful, the device could provide a more controlled way to cross the atrial septum, potentially reducing procedure time and acute complications.
How similar studies have performed: Radiofrequency transseptal techniques have been used previously and shown benefits for septal crossing, but this specific Agilis RF system is being tested first-in-human in this acute feasibility study.
Eligibility criteria
Show full inclusion / exclusion criteria
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 results
Where this trial is running
Jonesboro, Arkansas and 1 other locations
- Arrhythmia Research Group (St. Bernards) — Jonesboro, Arkansas, United States (Recruiting)
- California Pacific Medical Center -Van Ness Campus — San Francisco, California, United States (Recruiting)
Study contacts
- Study coordinator: Ben Gansemer, PhD
- Email: benjamin.gansemer@abbott.com
- Phone: +1 952-715-2719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.