ID

37563

Description

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

Link

https://clinicaltrials.gov/show/NCT01680757

Keywords

Versions (1)
  1. 8/7/19 8/7/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 7, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01680757

English

Eligibility Atrial Fibrillation NCT01680757

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. aged ≥ 21 years
Description

Age

Data type

boolean

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

Atrial Fibrillation | Exception Heart Valve Involvement

Data type

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
Description

CHADS2 score

Data type

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).
Description

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

Data type

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
Description

Life Expectancy

Data type

boolean

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

Compliance Follow-up visit

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

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
Description

Heart Valve Prosthesis | Heart Valve Sewing Ring

Data type

boolean

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

Heart failure Symptoms New York Heart Association Classification

Data type

boolean

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

Heart Failure, Right-Sided

Data type

boolean

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

Myocardial Infarction

Data type

boolean

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

Angina, Unstable

Data type

boolean

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

Shock, Cardiogenic | Hemodynamic instability

Data type

boolean

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

Carotid disease Symptomatic

Data type

boolean

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

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

Data type

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
Description

Embolic stroke

Data type

boolean

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

Transient Ischemic Attack

Data type

boolean

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

Sepsis

Data type

boolean

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

Estimated Glomerular Filtration Rate

Data type

boolean

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

Kidney Failure Requirement Dialysis

Data type

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)
Description

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

Data type

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
Description

Liver Cirrhosis

Data type

boolean

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

Radiotherapy to thorax

Data type

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
Description

Steroid therapy Long-term | Exception Inhaled steroids Respiration Disorders

Data type

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)
Description

Autoimmune Disease Associated with Pericarditis | Connective Tissue Diseases Specific

Data type

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
Description

Pericarditis

Data type

boolean

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

Pectus excavatum

Data type

boolean

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

Scoliosis, severe

Data type

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)
Description

Thrombocytopenia | Platelet Count measurement

Data type

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)
Description

Anemia | Hemoglobin measurement

Data type

boolean

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

Pregnancy | Pregnancy, Planned

Data type

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
Description

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

Data type

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
Description

Mental impairment | Study Protocol Comprehension Unable

Data type

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)
Description

Study Subject Participation Status Inappropriate | Substance Dependence Uncontrolled

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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