ID

37563

Beskrivning

Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation - III; ODM derived from: https://clinicaltrials.gov/show/NCT01680757

Länk

https://clinicaltrials.gov/show/NCT01680757

Nyckelord

Versioner (1)
  1. 2019-08-07 2019-08-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01680757

Engelsk

Eligibility Atrial Fibrillation NCT01680757

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. aged ≥ 21 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosed non-valvular atrial fibrillation
Beskrivning

Atrial Fibrillation | Exception Heart Valve Involvement

Datatyp

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018826
UMLS CUI [2,3]
C1314939
3. current chads2 score > 2
Beskrivning

CHADS2 score

Datatyp

boolean

Alias
UMLS CUI [1]
C2585876
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).
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0003281
UMLS CUI [3]
C0043031
UMLS CUI [4]
C2348066
UMLS CUI [5]
C1831808
UMLS CUI [6]
C1739768
UMLS CUI [7]
C0019080
UMLS CUI [8]
C4039184
UMLS CUI [9]
C1504327
UMLS CUI [10,1]
C1321605
UMLS CUI [10,2]
C0332268
UMLS CUI [10,3]
C0150457
UMLS CUI [11,1]
C0150457
UMLS CUI [11,2]
C0558080
UMLS CUI [12,1]
C0150457
UMLS CUI [12,2]
C0231175
UMLS CUI [13]
C0007787
UMLS CUI [14]
C0038454
5. life expectancy of at least 1 year
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
6. willing and able to return and comply with scheduled follow up visits
Beskrivning

Compliance Follow-up visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0589121
7. willing and able to provide written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior cardiac surgery involving opening of pericardium (e.g., cabg, heart transplantation, valve surgery)
Beskrivning

Cardiac Surgery Previous | Open approach Pericardium | Coronary Artery Bypass Surgery | Heart Transplantation | Operation on heart valve

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0348025
UMLS CUI [2,2]
C0031050
UMLS CUI [3]
C0010055
UMLS CUI [4]
C0018823
UMLS CUI [5]
C0190065
2. prosthetic heart valve or ring in any position
Beskrivning

Heart Valve Prosthesis | Heart Valve Sewing Ring

Datatyp

boolean

Alias
UMLS CUI [1]
C0018825
UMLS CUI [2]
C1708338
3. current nyha class iv heart failure symptoms
Beskrivning

Heart failure Symptoms New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1275491
4. current right heart failure
Beskrivning

Heart Failure, Right-Sided

Datatyp

boolean

Alias
UMLS CUI [1]
C0235527
5. myocardial infarction within last 3 months
Beskrivning

Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
6. unstable angina within last 3 months
Beskrivning

Angina, Unstable

Datatyp

boolean

Alias
UMLS CUI [1]
C0002965
7. current cardiogenic shock or hemodynamic instability
Beskrivning

Shock, Cardiogenic | Hemodynamic instability

Datatyp

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2]
C0948268
8. current symptomatic carotid disease
Beskrivning

Carotid disease Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0741975
UMLS CUI [1,2]
C0231220
9. need for an intra-aortic balloon pump or intravenous inotropes
Beskrivning

Patient need for Intra-aortic balloon pump | Patient need for Inotropic agent Intravenous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0702122
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0304509
UMLS CUI [2,3]
C1522726
10. embolic stroke within the last 30 days
Beskrivning

Embolic stroke

Datatyp

boolean

Alias
UMLS CUI [1]
C0262469
11. transient ischemic attack (tia) within the last 30 days
Beskrivning

Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0007787
12. current diagnosis of active systemic infection
Beskrivning

Sepsis

Datatyp

boolean

Alias
UMLS CUI [1]
C0243026
13. egfr < 60 ml/min/1.73m2 within last 3 months
Beskrivning

Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C3811844
14. current renal failure requiring dialysis
Beskrivning

Kidney Failure Requirement Dialysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
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)
Beskrivning

Alanine aminotransferase increased | Aspartate aminotransferase increased | Indication of Liver Failure | Assessment Before Interventional procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
UMLS CUI [3,1]
C0392360
UMLS CUI [3,2]
C0085605
UMLS CUI [4,1]
C1516048
UMLS CUI [4,2]
C0332152
UMLS CUI [4,3]
C0184661
16. current clinical evidence of cirrhosis
Beskrivning

Liver Cirrhosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0023890
17. any history of thoracic radiation
Beskrivning

Radiotherapy to thorax

Datatyp

boolean

Alias
UMLS CUI [1]
C4038705
18. current use of long term treatment with steroids, not including intermittent use of inhaled steroids for respiratory diseases
Beskrivning

Steroid therapy Long-term | Exception Inhaled steroids Respiration Disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0443252
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2065041
UMLS CUI [2,3]
C0035204
19. diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific connective tissue disorders)
Beskrivning

Autoimmune Disease Associated with Pericarditis | Connective Tissue Diseases Specific

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0031046
UMLS CUI [2,1]
C0009782
UMLS CUI [2,2]
C0205369
20. any history of pericarditis
Beskrivning

Pericarditis

Datatyp

boolean

Alias
UMLS CUI [1]
C0031046
21. pectus excavatum (clinically defined by treating physician)
Beskrivning

Pectus excavatum

Datatyp

boolean

Alias
UMLS CUI [1]
C2051831
22. severe scoliosis
Beskrivning

Scoliosis, severe

Datatyp

boolean

Alias
UMLS CUI [1]
C2674596
23. thrombocytopenia (platelet count < 100 x 109/l) based on most recent pre-procedure assessment (within 30 days of study treatment)
Beskrivning

Thrombocytopenia | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0032181
24. anemia with hemoglobin concentration of < 10 g/dl based on most recent pre-procedure assessment (within 30 days of study treatment)
Beskrivning

Anemia | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
25. pregnancy or desire to get pregnant within next 12 months.
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
26. current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this registry
Beskrivning

Study Subject Participation Status | Study | Investigational Medical Device Cardiovascular | Investigational New Drugs | Interference Registry

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008972
UMLS CUI [3,1]
C2346570
UMLS CUI [3,2]
C3887460
UMLS CUI [4]
C0013230
UMLS CUI [5,1]
C0521102
UMLS CUI [5,2]
C0034975
27. mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study
Beskrivning

Mental impairment | Study Protocol Comprehension Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C0683322
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0162340
UMLS CUI [2,3]
C1299582
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)
Beskrivning

Study Subject Participation Status Inappropriate | Substance Dependence Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C0038580
UMLS CUI [2,2]
C0205318
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Similar models

Eligibility Atrial Fibrillation NCT01680757

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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