AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Agilis RF TSP Early Feasibility Study

RecruitingNAAges 18 Years - anyAllAbbott Medical Devices
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

This study is a prospective, acute, first-in-human, early feasibility study intended to assess the initial safety and performance of the Agilisโ„ข 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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
๐Ÿ’Š

What it tests

  • Transseptal procedure with Agilis RF TSP System.
๐Ÿ“

Where

3 sites
Arrhythmia Research Group (St. Bernards)
Jonesboro, United States
California Pacific Medical Center -Van Ness Campus
San Francisco, United States
Research Medical Center
Kansas City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy