Confirm RX
Confirm Rx Insertable Cardiac Monitor SMART Registry
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Clinical Trial Information
Trial Contact: Pfeffer, Nicole; Delmontagne, Kim
Trial Phone: 727-893-6595 ; 727.893.6595
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IRB No: WIRB20192634
Protocol Abbrev: Confirm RX
Principal Investigator: Daniel Masvidal, MD
Phase: Device: Category N/A
Age Group: Adult
ClinicalTrials.gov ID: NCT03505801
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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.
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Key Eligibility
Indications for continuous Atrial Fibrilation monitoring with an Insertable Cardiac Monitor.
