ID

37474

Description

Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01182441

Link

https://clinicaltrials.gov/show/NCT01182441

Keywords

Versions (1)
  1. 7/31/19 7/31/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 31, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01182441

English

Eligibility Atrial Fibrillation NCT01182441

1 forms  
Criteria
Description

Criteria

paroxysmal, persistent or permanent non-valvular af
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
UMLS CUI [3]
C2586056
UMLS CUI [4,1]
C0018826
UMLS CUI [4,2]
C1314939
UMLS CUI [4,3]
C0332197
eligible for long-term warfarin therapy
Description

Eligibility Warfarin therapy Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C4303340
UMLS CUI [1,3]
C0443252
eligible to come off warfarin therapy
Description

Eligibility Warfarin therapy Discontinue

Data type

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C4303340
UMLS CUI [1,3]
C1444662
calculated chads2 score of 2 or greater. also patients with a chads2 score of 1 may be included if any of the following apply:
Description

CHADS2 score

Data type

boolean

Alias
UMLS CUI [1]
C2585876
female age 75 or older
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
baseline lvef ≥ 30 and < 35%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
aged 65-74 and has diabetes or coronary artery disease
Description

Age | Diabetes Mellitus | Coronary Artery Disease

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011849
UMLS CUI [3]
C1956346
aged 65 or greater and has congestive heart failure
Description

Age | Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0018802
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
contraindicated/allergic to aspirin
Description

Medical contraindication Aspirin | Aspirin allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004057
UMLS CUI [2]
C0004058
indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment
Description

Indication Clopidogrel | Clopidogrel

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0070166
UMLS CUI [2]
C0070166
history of atrial septal repair or has an asd/pfo device
Description

Atrioseptoplasty | ASD Device | PFO Device

Data type

boolean

Alias
UMLS CUI [1]
C0189965
UMLS CUI [2,1]
C0018817
UMLS CUI [2,2]
C0025080
UMLS CUI [3,1]
C0016522
UMLS CUI [3,2]
C0025080
implanted mechanical valve prosthesis
Description

Mechanical heart valve prosthesis Implanted

Data type

boolean

Alias
UMLS CUI [1,1]
C3873910
UMLS CUI [1,2]
C0021102
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
resting heart rate > 110 bpm
Description

Resting heart rate

Data type

boolean

Alias
UMLS CUI [1]
C1821417
participated previously in the protect af or cap registry studies
Description

Study Subject Participation Status | Clinical Trials Specified

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
key echo exclusion criteria:
Description

Echocardiography Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C1542147
lvef < 30%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
existing pericardial effusion > 2mm
Description

Pericardial effusion

Data type

boolean

Alias
UMLS CUI [1]
C0031039
high risk pfo
Description

High risk PFO

Data type

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0016522
significant mitral valve stenosis
Description

Mitral Valve Stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0026269
complex atheroma with mobile plaque of the descending aorta and/or aortic arch
Description

Atheroma Complex | Plaque Descending aorta | Plaque Aortic arch

Data type

boolean

Alias
UMLS CUI [1,1]
C0264956
UMLS CUI [1,2]
C0439855
UMLS CUI [2,1]
C2936350
UMLS CUI [2,2]
C0011666
UMLS CUI [3,1]
C2936350
UMLS CUI [3,2]
C0003489
cardiac tumor
Description

Heart Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0018809
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Similar models

Eligibility Atrial Fibrillation NCT01182441

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Permanent atrial fibrillation | Heart Valve Involvement Absent
Item
paroxysmal, persistent or permanent non-valvular af
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
C2586056 (UMLS CUI [3])
C0018826 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Eligibility Warfarin therapy Long-term
Item
eligible for long-term warfarin therapy
boolean
C1548635 (UMLS CUI [1,1])
C4303340 (UMLS CUI [1,2])
C0443252 (UMLS CUI [1,3])
Eligibility Warfarin therapy Discontinue
Item
eligible to come off warfarin therapy
boolean
C1548635 (UMLS CUI [1,1])
C4303340 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
CHADS2 score
Item
calculated chads2 score of 2 or greater. also patients with a chads2 score of 1 may be included if any of the following apply:
boolean
C2585876 (UMLS CUI [1])
Gender | Age
Item
female age 75 or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Left ventricular ejection fraction
Item
baseline lvef ≥ 30 and < 35%
boolean
C0428772 (UMLS CUI [1])
Age | Diabetes Mellitus | Coronary Artery Disease
Item
aged 65-74 and has diabetes or coronary artery disease
boolean
C0001779 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C1956346 (UMLS CUI [3])
Age | Congestive heart failure
Item
aged 65 or greater and has congestive heart failure
boolean
C0001779 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Medical contraindication Aspirin | Aspirin allergy
Item
contraindicated/allergic to aspirin
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0004058 (UMLS CUI [2])
Indication Clopidogrel | Clopidogrel
Item
indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment
boolean
C3146298 (UMLS CUI [1,1])
C0070166 (UMLS CUI [1,2])
C0070166 (UMLS CUI [2])
Atrioseptoplasty | ASD Device | PFO Device
Item
history of atrial septal repair or has an asd/pfo device
boolean
C0189965 (UMLS CUI [1])
C0018817 (UMLS CUI [2,1])
C0025080 (UMLS CUI [2,2])
C0016522 (UMLS CUI [3,1])
C0025080 (UMLS CUI [3,2])
Mechanical heart valve prosthesis Implanted
Item
implanted mechanical valve prosthesis
boolean
C3873910 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
Congestive heart failure New York Heart Association Classification
Item
nyha class iv chf
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Resting heart rate
Item
resting heart rate > 110 bpm
boolean
C1821417 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trials Specified
Item
participated previously in the protect af or cap registry studies
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Echocardiography Exclusion Criteria Main
Item
key echo exclusion criteria:
boolean
C0013516 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,3])
Left ventricular ejection fraction
Item
lvef < 30%
boolean
C0428772 (UMLS CUI [1])
Pericardial effusion
Item
existing pericardial effusion > 2mm
boolean
C0031039 (UMLS CUI [1])
High risk PFO
Item
high risk pfo
boolean
C0332167 (UMLS CUI [1,1])
C0016522 (UMLS CUI [1,2])
Mitral Valve Stenosis
Item
significant mitral valve stenosis
boolean
C0026269 (UMLS CUI [1])
Atheroma Complex | Plaque Descending aorta | Plaque Aortic arch
Item
complex atheroma with mobile plaque of the descending aorta and/or aortic arch
boolean
C0264956 (UMLS CUI [1,1])
C0439855 (UMLS CUI [1,2])
C2936350 (UMLS CUI [2,1])
C0011666 (UMLS CUI [2,2])
C2936350 (UMLS CUI [3,1])
C0003489 (UMLS CUI [3,2])
Heart Neoplasm
Item
cardiac tumor
boolean
C0018809 (UMLS CUI [1])
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