Agilis RF TSP Early Feasibility Study

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
Abbott Medical Devices
Study ID
NCT07361445
Status
Recruiting
Apply to this trial

Conditions

  • Cardiac Arrythmias
  • Left Atrial Appendage Closure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transseptal procedure with Agilis RF TSP System. — DEVICE
    Radiofrequency wire will be used for the transseptal procedure.

Study Details

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.

Key Dates

Start date
Feb 16, 2026
Status verified
May 2026
Primary completion
Jun 1, 2026
Completion
Aug 3, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Transseptal Procedure

Primary Outcome Measure

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Arrhythmia Research Group (St. Bernards)JonesboroArkansas72401-
California Pacific Medical Center -Van Ness CampusSan FranciscoCalifornia94109-
Research Medical CenterKansas CityMissouri64132-

Find similar trials in Jonesboro, AR

By research site
Arrhythmia Research Group (St. Bernards)· Jonesboro, ARCalifornia Pacific Medical Center -Van Ness Campus· San Francisco, CAResearch Medical Center· Kansas City, MO

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