ID

25898

Description

Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE); ODM derived from: https://clinicaltrials.gov/show/NCT01196897

Link

https://clinicaltrials.gov/show/NCT01196897

Keywords

  1. 9/25/17 9/25/17 -
  2. 9/26/17 9/26/17 -
Uploaded on

September 26, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT01196897

Eligibility Atrial Fibrillation NCT01196897

Criteria
Description

Criteria

paroxysmal, persistent, or permanent non-valvular atrial fibrillation
Description

Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Permanent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
UMLS CUI [3]
C2586056
eligible for long-term warfarin therapy;
Description

Warfarin Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C0043031
UMLS CUI [1,2]
C0443252
eligible to come off warfarin therapy if the laa is sealed
Description

Warfarin Discontinue | Left atrium appendage Closed

Data type

boolean

Alias
UMLS CUI [1,1]
C0043031
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0225860
UMLS CUI [2,2]
C0598782
UMLS CUI [2,3]
C0587267
calculated chads2 score of 1 or greater
Description

CHADS2 score

Data type

boolean

Alias
UMLS CUI [1]
C2585876
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
new york heart association class iv congestive heart failure
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
recent mi (within 3 months)
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
asd and/or atrial septal repair or closure device
Description

Atrial Closure Device

Data type

boolean

Alias
UMLS CUI [1]
C2825201
resting heart rate >110 bpm
Description

RESTING HEART RATE

Data type

boolean

Alias
UMLS CUI [1]
C1821417
has an implanted mechanical valve prosthesis
Description

Mechanical prosthetic valve Implanted

Data type

boolean

Alias
UMLS CUI [1,1]
C4062429
UMLS CUI [1,2]
C0021102
left atrial appendage is obliterated
Description

Left atrium appendage Obliteration

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0598782
UMLS CUI [1,3]
C1283061
has undergone heart transplantation
Description

Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0018823
has symptomatic carotid disease
Description

Carotid disease Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0741975
UMLS CUI [1,2]
C0231220
contraindicated for aspirin
Description

Medical contraindication Aspirin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0004057
lvef < 30%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
cardiac tumor
Description

Heart Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C0018809

Similar models

Eligibility Atrial Fibrillation NCT01196897

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Permanent atrial fibrillation
Item
paroxysmal, persistent, or permanent non-valvular atrial fibrillation
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
C2586056 (UMLS CUI [3])
Warfarin Long-term
Item
eligible for long-term warfarin therapy;
boolean
C0043031 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
Warfarin Discontinue | Left atrium appendage Closed
Item
eligible to come off warfarin therapy if the laa is sealed
boolean
C0043031 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0225860 (UMLS CUI [2,1])
C0598782 (UMLS CUI [2,2])
C0587267 (UMLS CUI [2,3])
CHADS2 score
Item
calculated chads2 score of 1 or greater
boolean
C2585876 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Congestive heart failure New York Heart Association Classification
Item
new york heart association class iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction
Item
recent mi (within 3 months)
boolean
C0027051 (UMLS CUI [1])
Atrial Closure Device
Item
asd and/or atrial septal repair or closure device
boolean
C2825201 (UMLS CUI [1])
RESTING HEART RATE
Item
resting heart rate >110 bpm
boolean
C1821417 (UMLS CUI [1])
Mechanical prosthetic valve Implanted
Item
has an implanted mechanical valve prosthesis
boolean
C4062429 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
Left atrium appendage Obliteration
Item
left atrial appendage is obliterated
boolean
C0225860 (UMLS CUI [1,1])
C0598782 (UMLS CUI [1,2])
C1283061 (UMLS CUI [1,3])
Heart Transplantation
Item
has undergone heart transplantation
boolean
C0018823 (UMLS CUI [1])
Carotid disease Symptomatic
Item
has symptomatic carotid disease
boolean
C0741975 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Medical contraindication Aspirin
Item
contraindicated for aspirin
boolean
C1301624 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
lvef < 30%
boolean
C0428772 (UMLS CUI [1])
Heart Neoplasm
Item
cardiac tumor
boolean
C0018809 (UMLS CUI [1])

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