DEtermining Accuracy and TrEnding CharacTerization of AF
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Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording. [ Time Frame: 4 days after Holter starts ]
Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM.
Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Primary Care Clinic
The subject has been implanted with a SJM Confirm ICM, DM2102.
The subject has or is suspected to have paroxysmal AF.
The subject is ≥ 18 years of age.
The subject is willing and able to provide written Informed Consent (prior to any investigational related procedure).
The subject has persistent (>7 days and ≤1 year or requiring cardioversion), longstanding persistent (continuous AF >1 year) or permanent AF (not attempting to restore sinus rhythm).
The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid disease).
The subject has a contraindication to Holter recording.
The subject has already received an active implantable medical device other than the SJM Confirm ICM, DM2102.
The subject is unable to comply with the follow up schedule.
The subject is participating in another investigational device or drug investigation.
The subject is pregnant or is planning to become pregnant during the duration of the investigation.