The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a 12 month period. A sub-set of subjects enrolled in the Confirm Rx SMART Registry will meet the Post Market Clinical Follow-Up (PMCF) requirement for CE mark.
Study Type
OBSERVATIONAL
Enrollment
1,826
Insertion of Confirm Rx ICM device
Freedom from device SADEs and serious procedure related SAEs
Time frame: 1 month post insertion procedure
Freedom from device SADEs and serious procedure related SAEs
Time frame: 12 months post insertion procedure
R wave amplitude
Time frame: 12 months post insertion procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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