Informações:
Falhas:
ID
34790
Descrição
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
Palavras-chave
Versões (1)
- 29/1/19 29/1/19 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
29 de enero de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02105584
Eligibility Atrial Fibrillation NCT02105584
- StudyEvent: Eligibility
Similar models
Eligibility Atrial Fibrillation NCT02105584
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])