Confirm RX

Confirm Rx Insertable Cardiac Monitor SMART Registry

  • Clinical Trial Information

    Trial Contact: Pfeffer, Nicole; Delmontagne, Kim

    Trial Phone: 727-893-6595 ; 727.893.6595

  • IRB No: WIRB20192634

    Protocol Abbrev: Confirm RX

    Principal Investigator: Daniel Masvidal, MD

    Phase: Device: Category N/A

    Age Group: Adult ID: NCT03505801

  • Objective

    The primary objective is to evaluate the freedom from serious adverse device effects (SADEs) and procedure related serious adverse events (SAEs) through 1-month post insertion procedure. Additionally, the study will assess the impact to quality of life in subjects inserted with the Confirm RX ICM device and provide feedback on the user experience with the Confirm RX ICM device and system.

  • Key Eligibility

    Indications for continuous Atrial Fibrilation monitoring with an Insertable Cardiac Monitor.