Cardiac Arrythmias, Left Atrial Appendage Closure
Conditions
Brief 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.
Interventions
DEVICETransseptal procedure with Agilis RF TSP System.
Radiofrequency wire will be used for the transseptal procedure.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | During the procedure and periprocedurally | The primary safety endpoint is the 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. |
| Primary Effectiveness Endpoint: Rate of successful transseptal access indicated by the physician. | Procedure | The primary effectiveness endpoint is the rate of successful transseptal access indicated by the physician. |
Countries
United States
Contacts
CONTACTBen Gansemer, PhD
CONTACTAmber Miller, PhD
Outcome results
None listed