ID

34790

Beschrijving

Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage (LAA) in Patients With Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT02105584

Link

https://clinicaltrials.gov/show/NCT02105584

Trefwoorden

Versies (1)
  1. 29-01-19 29-01-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

29 januari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02105584

Engels

Eligibility Atrial Fibrillation NCT02105584

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented paroxysmal, persistent or chronic non-valvular af
Beschrijving

Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Chronic atrial fibrillation | Heart Valve Involvement Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
UMLS CUI [3]
C0694539
UMLS CUI [4,1]
C0018826
UMLS CUI [4,2]
C1314939
UMLS CUI [4,3]
C0332197
calculated cha2ds2 -vasc score equal or greater than 2 and/or has-bled score equal or greater than 2
Beschrijving

CHA2DS2-VASc score | HAS-BLED score

Datatype

boolean

Alias
UMLS CUI [1]
C4049268
UMLS CUI [2]
C3875442
patients eligible or non-eligible for lifelong, oral anticoagulation therapy
Beschrijving

Eligibility Anticoagulation Therapy Oral Lifelong | Lacking Eligibility Anticoagulation Therapy Oral Lifelong

Datatype

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0003281
UMLS CUI [1,3]
C1527415
UMLS CUI [1,4]
C4274169
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C1548635
UMLS CUI [2,3]
C0003281
UMLS CUI [2,4]
C1527415
UMLS CUI [2,5]
C4274169
life expectancy of at least 1 year
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
written, informed consent by the patient or her/his legally-authorized representative for participation in the study
Beschrijving

Informed Consent | Informed Consent Patient Representative

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
suspected or known intracardiac thrombus
Beschrijving

Intracardiac Thrombus Suspected | Intracardiac Thrombus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0876998
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C0876998
nyha class iv chf
Beschrijving

Congestive heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
patients who has unstable and intractable angina pectoris
Beschrijving

Angina, Unstable | Angina Pectoris intractable

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205269
asd and/or atrial septal repair or closure device
Beschrijving

Atrial Septal Defects | Atrioseptoplasty | Atrial Closure Device

Datatype

boolean

Alias
UMLS CUI [1]
C0018817
UMLS CUI [2]
C0189965
UMLS CUI [3]
C2825201
recent myocardial infarction within 3 months
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
severe valvular heart disease, or implanted mechanical valve prosthesis
Beschrijving

Heart valve disease Severe | Mechanical heart valve prosthesis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3873910
large pfo with significant atrial septal aneurysm
Beschrijving

Patent Foramen Ovale Large | Atrial septal aneurysm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0016522
UMLS CUI [1,2]
C0549177
UMLS CUI [2]
C0521533
planned ablation procedure within 30 days of occlutech laa occluder® implant
Beschrijving

Ablation Planned | Other Coding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0547070
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C3846158
resting heart rate > 110 bpm
Beschrijving

Resting heart rate

Datatype

boolean

Alias
UMLS CUI [1]
C1821417
allergy to nitinol, which is a result of nickel and/or titanium allergies
Beschrijving

Hypersensitivity Nitinol | Etiology Allergy to nickel | Etiology Hypersensitivity Titanium

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0068790
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1690547
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0020517
UMLS CUI [3,3]
C0040302
stroke/tia within the last 30 days
Beschrijving

Cerebrovascular accident | Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
thrombocytopenia, thrombocytosis, leukopenia, or anemia
Beschrijving

Thrombocytopenia | Thrombocytosis | Leukopenia | Anemia

Datatype

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0836924
UMLS CUI [3]
C0023530
UMLS CUI [4]
C0002871
symptomatic carotid artery disease
Beschrijving

Carotid Artery Disease Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007273
UMLS CUI [1,2]
C0231220
lvef < 30%
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
mitral valve stenosis
Beschrijving

Mitral Valve Stenosis

Datatype

boolean

Alias
UMLS CUI [1]
C0026269
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Similar models

Eligibility Atrial Fibrillation NCT02105584

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Chronic atrial fibrillation | Heart Valve Involvement Absent
Item
documented paroxysmal, persistent or chronic non-valvular af
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
C0694539 (UMLS CUI [3])
C0018826 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
CHA2DS2-VASc score | HAS-BLED score
Item
calculated cha2ds2 -vasc score equal or greater than 2 and/or has-bled score equal or greater than 2
boolean
C4049268 (UMLS CUI [1])
C3875442 (UMLS CUI [2])
Eligibility Anticoagulation Therapy Oral Lifelong | Lacking Eligibility Anticoagulation Therapy Oral Lifelong
Item
patients eligible or non-eligible for lifelong, oral anticoagulation therapy
boolean
C1548635 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
C4274169 (UMLS CUI [1,4])
C0332268 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C0003281 (UMLS CUI [2,3])
C1527415 (UMLS CUI [2,4])
C4274169 (UMLS CUI [2,5])
Life Expectancy
Item
life expectancy of at least 1 year
boolean
C0023671 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative
Item
written, informed consent by the patient or her/his legally-authorized representative for participation in the study
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Intracardiac Thrombus Suspected | Intracardiac Thrombus
Item
suspected or known intracardiac thrombus
boolean
C0876998 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0876998 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification
Item
nyha class iv chf
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Angina, Unstable | Angina Pectoris intractable
Item
patients who has unstable and intractable angina pectoris
boolean
C0002965 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Atrial Septal Defects | Atrioseptoplasty | Atrial Closure Device
Item
asd and/or atrial septal repair or closure device
boolean
C0018817 (UMLS CUI [1])
C0189965 (UMLS CUI [2])
C2825201 (UMLS CUI [3])
Myocardial Infarction
Item
recent myocardial infarction within 3 months
boolean
C0027051 (UMLS CUI [1])
Heart valve disease Severe | Mechanical heart valve prosthesis
Item
severe valvular heart disease, or implanted mechanical valve prosthesis
boolean
C0018824 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3873910 (UMLS CUI [2])
Patent Foramen Ovale Large | Atrial septal aneurysm
Item
large pfo with significant atrial septal aneurysm
boolean
C0016522 (UMLS CUI [1,1])
C0549177 (UMLS CUI [1,2])
C0521533 (UMLS CUI [2])
Ablation Planned | Other Coding
Item
planned ablation procedure within 30 days of occlutech laa occluder® implant
boolean
C0547070 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Resting heart rate
Item
resting heart rate > 110 bpm
boolean
C1821417 (UMLS CUI [1])
Hypersensitivity Nitinol | Etiology Allergy to nickel | Etiology Hypersensitivity Titanium
Item
allergy to nitinol, which is a result of nickel and/or titanium allergies
boolean
C0020517 (UMLS CUI [1,1])
C0068790 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C1690547 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
C0040302 (UMLS CUI [3,3])
Cerebrovascular accident | Transient Ischemic Attack
Item
stroke/tia within the last 30 days
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Thrombocytopenia | Thrombocytosis | Leukopenia | Anemia
Item
thrombocytopenia, thrombocytosis, leukopenia, or anemia
boolean
C0040034 (UMLS CUI [1])
C0836924 (UMLS CUI [2])
C0023530 (UMLS CUI [3])
C0002871 (UMLS CUI [4])
Carotid Artery Disease Symptomatic
Item
symptomatic carotid artery disease
boolean
C0007273 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
lvef < 30%
boolean
C0428772 (UMLS CUI [1])
Mitral Valve Stenosis
Item
mitral valve stenosis
boolean
C0026269 (UMLS CUI [1])
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