ID

34790

Description

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

Keywords

Versions (1)
  1. 1/29/19 1/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 29, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Atrial Fibrillation NCT02105584

English

Eligibility Atrial Fibrillation NCT02105584

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

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

Data type

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
Description

CHA2DS2-VASc score | HAS-BLED score

Data type

boolean

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

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

Data type

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
Description

Life Expectancy

Data type

boolean

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

Informed Consent | Informed Consent Patient Representative

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
suspected or known intracardiac thrombus
Description

Intracardiac Thrombus Suspected | Intracardiac Thrombus

Data type

boolean

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

Congestive heart failure New York Heart Association Classification

Data type

boolean

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

Angina, Unstable | Angina Pectoris intractable

Data type

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
Description

Atrial Septal Defects | Atrioseptoplasty | Atrial Closure Device

Data type

boolean

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

Myocardial Infarction

Data type

boolean

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

Heart valve disease Severe | Mechanical heart valve prosthesis

Data type

boolean

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

Patent Foramen Ovale Large | Atrial septal aneurysm

Data type

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
Description

Ablation Planned | Other Coding

Data type

boolean

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

Resting heart rate

Data type

boolean

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

Hypersensitivity Nitinol | Etiology Allergy to nickel | Etiology Hypersensitivity Titanium

Data type

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
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

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

Thrombocytopenia | Thrombocytosis | Leukopenia | Anemia

Data type

boolean

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

Carotid Artery Disease Symptomatic

Data type

boolean

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

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
mitral valve stenosis
Description

Mitral Valve Stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0026269
Back to the top of the page

Similar models

Eligibility Atrial Fibrillation NCT02105584

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial