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
ClinicalTrials.gov ID: NCT03505801
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.
Indications for continuous Atrial Fibrilation monitoring with an Insertable Cardiac Monitor.