An observational study in Cardiac Arrhythmias, Symptoms and Signs and Atrial Fibrillation, sponsored by Abbott Medical Devices. Completed at 113 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Abbott Medical Devices · Observational
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.
Subjects over the age of 18 years (or of legal age specific to state and national law) who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as subjects who are at risk for cardiac arrhythmias, have been previously diagnosed with atrial fibrillation, or who are susceptible to developing atrial fibrillation.
Exclusion Criteria:
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
Showing the first 100 of 113 sites across 24 countries.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Abbott Medical Devices