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The interventional phase is followed by an observational phase as long as the patient is implanted with the ICM, but only the device's data will be collected. Screening and selection takes place before the PFO's closure is finalized, and an informed consent form is signed. Patients who will have the ICM for a long time after a 6-month follow-up period have an observational period.
Source link: https://clinicaltrials.gov/ct2/show/NCT05213104
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