Agilis RF TSP Early Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Transseptal procedure with Agilis RF TSP System.
DeviceRadiofrequency wire will be used for the transseptal procedure.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Transseptal ProcedureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
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.
Time frame
During the procedure and periprocedurally2
Primary Effectiveness Endpoint: Rate of successful transseptal access indicated by the physician.
The primary effectiveness endpoint is the rate of successful transseptal access indicated by the physician.
Time frame
ProcedureSponsors and contacts
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Source ClinicalTrials.gov