Age
Item
1. aged ≥ 21 years
boolean
C0001779 (UMLS CUI [1])
Atrial Fibrillation | Exception Heart Valve Involvement
Item
2. diagnosed non-valvular atrial fibrillation
boolean
C0004238 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018826 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
CHADS2 score
Item
3. current chads2 score > 2
boolean
C2585876 (UMLS CUI [1])
Medical contraindication Anticoagulation Therapy | Intolerance to Anticoagulation Therapy | Warfarin | dabigatran | apixaban | rivaroxaban | Hemorrhage | High risk of bleeding | International normalised ratio fluctuation | Compliance Lacking Anticoagulant therapy | Anticoagulant therapy Unwilling | Anticoagulant therapy failed | Transient Ischemic Attack | Cerebrovascular accident
Item
4. currently contraindicated to or intolerant of standard anticoagulation therapy (i.e., warfarin, dabigatran, apixaban, and rivaroxaban) due to at least one of the following: history of bleeding or high risk of bleeding; labile inr level (while on anticoagulation therapy, participant had inr results "out of therapeutic range" > 40% of the time, over a minimum period of 2 months.); non-compliant, unwilling to take, or anticoagulant failure (e.g., tia or stroke while on anticoagulant therapy).
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0003281 (UMLS CUI [2,2])
C0043031 (UMLS CUI [3])
C2348066 (UMLS CUI [4])
C1831808 (UMLS CUI [5])
C1739768 (UMLS CUI [6])
C0019080 (UMLS CUI [7])
C4039184 (UMLS CUI [8])
C1504327 (UMLS CUI [9])
C1321605 (UMLS CUI [10,1])
C0332268 (UMLS CUI [10,2])
C0150457 (UMLS CUI [10,3])
C0150457 (UMLS CUI [11,1])
C0558080 (UMLS CUI [11,2])
C0150457 (UMLS CUI [12,1])
C0231175 (UMLS CUI [12,2])
C0007787 (UMLS CUI [13])
C0038454 (UMLS CUI [14])
Life Expectancy
Item
5. life expectancy of at least 1 year
boolean
C0023671 (UMLS CUI [1])
Compliance Follow-up visit
Item
6. willing and able to return and comply with scheduled follow up visits
boolean
C1321605 (UMLS CUI [1,1])
C0589121 (UMLS CUI [1,2])
Informed Consent
Item
7. willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Cardiac Surgery Previous | Open approach Pericardium | Coronary Artery Bypass Surgery | Heart Transplantation | Operation on heart valve
Item
1. prior cardiac surgery involving opening of pericardium (e.g., cabg, heart transplantation, valve surgery)
boolean
C0018821 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0348025 (UMLS CUI [2,1])
C0031050 (UMLS CUI [2,2])
C0010055 (UMLS CUI [3])
C0018823 (UMLS CUI [4])
C0190065 (UMLS CUI [5])
Heart Valve Prosthesis | Heart Valve Sewing Ring
Item
2. prosthetic heart valve or ring in any position
boolean
C0018825 (UMLS CUI [1])
C1708338 (UMLS CUI [2])
Heart failure Symptoms New York Heart Association Classification
Item
3. current nyha class iv heart failure symptoms
boolean
C0018801 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Heart Failure, Right-Sided
Item
4. current right heart failure
boolean
C0235527 (UMLS CUI [1])
Myocardial Infarction
Item
5. myocardial infarction within last 3 months
boolean
C0027051 (UMLS CUI [1])
Angina, Unstable
Item
6. unstable angina within last 3 months
boolean
C0002965 (UMLS CUI [1])
Shock, Cardiogenic | Hemodynamic instability
Item
7. current cardiogenic shock or hemodynamic instability
boolean
C0036980 (UMLS CUI [1])
C0948268 (UMLS CUI [2])
Carotid disease Symptomatic
Item
8. current symptomatic carotid disease
boolean
C0741975 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Patient need for Intra-aortic balloon pump | Patient need for Inotropic agent Intravenous
Item
9. need for an intra-aortic balloon pump or intravenous inotropes
boolean
C0686904 (UMLS CUI [1,1])
C0702122 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C0304509 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
Embolic stroke
Item
10. embolic stroke within the last 30 days
boolean
C0262469 (UMLS CUI [1])
Transient Ischemic Attack
Item
11. transient ischemic attack (tia) within the last 30 days
boolean
C0007787 (UMLS CUI [1])
Sepsis
Item
12. current diagnosis of active systemic infection
boolean
C0243026 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
13. egfr < 60 ml/min/1.73m2 within last 3 months
boolean
C3811844 (UMLS CUI [1])
Kidney Failure Requirement Dialysis
Item
14. current renal failure requiring dialysis
boolean
C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Indication of Liver Failure | Assessment Before Interventional procedure
Item
15. alt or ast level > 3 times upper level of normal, indicating hepatic failure. (note: normal range provided by local laboratory performing the measurement), based on most recent pre-procedure assessment (within 30 days of study treatment)
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0392360 (UMLS CUI [3,1])
C0085605 (UMLS CUI [3,2])
C1516048 (UMLS CUI [4,1])
C0332152 (UMLS CUI [4,2])
C0184661 (UMLS CUI [4,3])
Liver Cirrhosis
Item
16. current clinical evidence of cirrhosis
boolean
C0023890 (UMLS CUI [1])
Radiotherapy to thorax
Item
17. any history of thoracic radiation
boolean
C4038705 (UMLS CUI [1])
Steroid therapy Long-term | Exception Inhaled steroids Respiration Disorders
Item
18. current use of long term treatment with steroids, not including intermittent use of inhaled steroids for respiratory diseases
boolean
C0149783 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2065041 (UMLS CUI [2,2])
C0035204 (UMLS CUI [2,3])
Autoimmune Disease Associated with Pericarditis | Connective Tissue Diseases Specific
Item
19. diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific connective tissue disorders)
boolean
C0004364 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0031046 (UMLS CUI [1,3])
C0009782 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Pericarditis
Item
20. any history of pericarditis
boolean
C0031046 (UMLS CUI [1])
Pectus excavatum
Item
21. pectus excavatum (clinically defined by treating physician)
boolean
C2051831 (UMLS CUI [1])
Scoliosis, severe
Item
22. severe scoliosis
boolean
C2674596 (UMLS CUI [1])
Thrombocytopenia | Platelet Count measurement
Item
23. thrombocytopenia (platelet count < 100 x 109/l) based on most recent pre-procedure assessment (within 30 days of study treatment)
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Anemia | Hemoglobin measurement
Item
24. anemia with hemoglobin concentration of < 10 g/dl based on most recent pre-procedure assessment (within 30 days of study treatment)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Pregnancy | Pregnancy, Planned
Item
25. pregnancy or desire to get pregnant within next 12 months.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Study Subject Participation Status | Study | Investigational Medical Device Cardiovascular | Investigational New Drugs | Interference Registry
Item
26. current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this registry
boolean
C2348568 (UMLS CUI [1])
C0008972 (UMLS CUI [2])
C2346570 (UMLS CUI [3,1])
C3887460 (UMLS CUI [3,2])
C0013230 (UMLS CUI [4])
C0521102 (UMLS CUI [5,1])
C0034975 (UMLS CUI [5,2])
Mental impairment | Study Protocol Comprehension Unable
Item
27. mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study
boolean
C0683322 (UMLS CUI [1])
C2348563 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Study Subject Participation Status Inappropriate | Substance Dependence Uncontrolled
Item
28. any other criteria, which would make the patient unsuitable to participate in this study as determined by clinical site principal investigator (e.g., an uncontrolled drug and/or alcohol addiction)
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0038580 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])