Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Legal Adult More Than Minimum
Item
male or female older than minimum legal adult age (country specific)
boolean
C1706450 (UMLS CUI [1,1])
C0439093 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
Atrial Fibrillation Duration
Item
ongoing af lasting at least 48 hrs but <= 12 months
boolean
C0004238 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Electrical cardioversion Planned
Item
subject planned for electrical cardioversion
boolean
C0013778 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Atrial Fibrillation Transient | Atrial Fibrillation Reversible
Item
.af that is transient or reversible
boolean
C0004238 (UMLS CUI [1,1])
C0205374 (UMLS CUI [1,2])
C0004238 (UMLS CUI [2,1])
C0205343 (UMLS CUI [2,2])
Rhythm issue | Exception Atrial Fibrillation
Item
no other rhythm issues other than af
boolean
C0871269 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
Mitral Stenosis | Rheumatism | Atrial myxoma Unresected | Mechanical heart valve
Item
mitral stenosis or rheumatic disease, unresected atrial myxoma or mechanical heart valve
boolean
C0026269 (UMLS CUI [1])
C0035435 (UMLS CUI [2])
C0151241 (UMLS CUI [3,1])
C2986425 (UMLS CUI [3,2])
C0493527 (UMLS CUI [4])
Atrial appendage closure Left | Thrombus of left atrium
Item
left atrial appendage closure or thrombus
boolean
C4523927 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
C3532827 (UMLS CUI [2])
Myocardial Infarction | Cerebrovascular accident | Acute Coronary Syndrome | Percutaneous Coronary Intervention
Item
mi, stroke, acs, pci within 30 days
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0948089 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
High risk of bleeding
Item
high risk of bleeding within 10 days or randomization
boolean
C4039184 (UMLS CUI [1])
Antiplatelet therapy Dual
Item
dual antiplatelet therapy
boolean
C1096021 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
Illicit medication use
Item
list of prohibited concomitant medication
boolean
C0281875 (UMLS CUI [1])
Liver disease
Item
active liver disease
boolean
C0023895 (UMLS CUI [1])
Kidney Failure | Creatinine clearance measurement
Item
renal failure, crcl < 15 ml/min
boolean
C0035078 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Hemoglobin measurement | Platelet Count measurement
Item
hemoglobin < 10g/dl or platelet count < 100000 cells/microliter
boolean
C0518015 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Investigational New Drugs
Item
taking other investigational drugs
boolean
C0013230 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential with proper contraceptives measures
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Malignant Neoplasms Requiring Chemotherapy | Malignant Neoplasms Requiring Therapeutic radiology procedure | Malignant Neoplasms Requiring Operative Surgical Procedures
Item
active cancer requiring chemotherapy/radiation/surgery
boolean
C0006826 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0543467 (UMLS CUI [3,3])
Investigator Judgment Medical Examination Related
Item
investigator discretion based on examination
boolean
C0035173 (UMLS CUI [1,1])
C0022423 (UMLS CUI [1,2])
C0582103 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])