Agilis RF TSP Early Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transseptal procedure with Agilis RF TSP System..
- Who it may be relevant to
- Registry conditions: Cardiac Arrythmias, Left Atrial Appendage Closure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Agilis Radiofrequency Transseptal System Early Feasibility Study
Overview
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
- Device Transseptal procedure with Agilis RF TSP System.
Radiofrequency wire will be used for the transseptal procedure.
Primary outcome measures
- 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. [Time frame: During the procedure and periprocedurally]
- Primary Effectiveness Endpoint: Rate of successful transseptal access indicated by the physician. [Time frame: Procedure]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 3 centers
- Arrhythmia Research Group (St. Bernards) — Jonesboro
- California Pacific Medical Center -Van Ness Campus — San Francisco
- Research Medical Center — Kansas City
Identifiers
NCT: NCT07361445 · ABT-CIP-10601