Implantable cardiac monitor Specified Implanted
Item
the subject has been implanted with a sjm confirm icm, dm2102.
boolean
C3879681 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0021102 (UMLS CUI [1,3])
Paroxysmal atrial fibrillation | Paroxysmal atrial fibrillation Suspected
Item
the subject has or is suspected to have paroxysmal af.
boolean
C0235480 (UMLS CUI [1])
C0235480 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Age
Item
the subject is ≥ 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
the subject is willing and able to provide written informed consent (prior to any investigational related procedure).
boolean
C0021430 (UMLS CUI [1])
Persistent atrial fibrillation Disease length | Persistent atrial fibrillation Requirement Electric Countershock | Longstanding persistent atrial fibrillation Disease length | Permanent atrial fibrillation
Item
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).
boolean
C2585653 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C2585653 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013778 (UMLS CUI [2,3])
C3873617 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
C2586056 (UMLS CUI [4])
Atrial Fibrillation Etiology Reversible | Electrolyte imbalance | Thyroid Disease
Item
the subject has af of reversible etiology (e.g. electrolyte imbalance, thyroid disease).
boolean
C0004238 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0205343 (UMLS CUI [1,3])
C0342579 (UMLS CUI [2])
C0040128 (UMLS CUI [3])
Medical contraindication Holter Electrocardiography
Item
the subject has a contraindication to holter recording.
boolean
C1301624 (UMLS CUI [1,1])
C0013801 (UMLS CUI [1,2])
Implant Received | Exception Implantable cardiac monitor Specified
Item
the subject has already received an active implantable medical device other than the sjm confirm icm, dm2102.
boolean
C0021102 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C3879681 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Compliance behavior Follow-up Unable
Item
the subject is unable to comply with the follow up schedule.
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs
Item
the subject is participating in another investigational device or drug investigation.
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Pregnancy | Pregnancy, Planned
Item
the subject is pregnant or is planning to become pregnant during the duration of the investigation.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])