ID

35509

Description

The V-Wave Shunt: FIM Safety and Feasibility Study; ODM derived from: https://clinicaltrials.gov/show/NCT01965015

Link

https://clinicaltrials.gov/show/NCT01965015

Keywords

Versions (1)
  1. 3/6/19 3/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 6, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT01965015

English

Eligibility Congestive Heart Failure NCT01965015

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is ≥ 18 and < 85 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient has chronic ischemic or non-ischemic cardiomyopathy nyha class iii or ambulatory class iv heart failure despite optimal medical therapy
Description

Ischemic cardiomyopathy chronic New York Heart Association Classification | Non-ischemic cardiomyopathy chronic New York Heart Association Classification | Heart failure Ambulatory New York Heart Association Classification | Therapy Optimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0349782
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0877438
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C1275491
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C0439841
UMLS CUI [3,3]
C1275491
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C2698651
patient lvef > 15% and ≤ 40%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
patient has elevated left atrial pressure (lap)
Description

Elevated left atrial pressure

Data type

boolean

Alias
UMLS CUI [1]
C4531219
patient has normal right atrial pressure (rap)
Description

Right atrial pressure Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0456165
UMLS CUI [1,2]
C0205307
bnp or ntprobnp levels are >300 or >1500 pg/ml, respectively
Description

Brain natriuretic peptide measurement | NT-proBNP Level

Data type

boolean

Alias
UMLS CUI [1]
C1095989
UMLS CUI [2,1]
C0754710
UMLS CUI [2,2]
C0441889
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
right heart failure
Description

Heart Failure, Right-Sided

Data type

boolean

Alias
UMLS CUI [1]
C0235527
ongoing malignant disease
Description

Malignant disease

Data type

boolean

Alias
UMLS CUI [1]
C0442867
thromboembolic event within the last 6 months
Description

Thromboembolism

Data type

boolean

Alias
UMLS CUI [1]
C0040038
acute or chronic renal insufficiency
Description

Renal Insufficiency | Chronic Kidney Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0403447
congenital heart disease
Description

Congenital heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0152021
severe pulmonary hypertension
Description

Pulmonary Hypertension Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0205082
atrial fibrillation (persistent/permanent)
Description

Persistent atrial fibrillation | Permanent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2]
C2586056
severe mitral regurgitation
Description

Mitral regurgitation Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0026266
UMLS CUI [1,2]
C0205082
la thrombus or deep vein thrombosis (dvt)
Description

Thrombus Arterial | Deep Vein Thrombosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0087086
UMLS CUI [1,2]
C0221464
UMLS CUI [2]
C0149871
severe restrictive or obstructive lung disease
Description

Restrictive lung disease Severe | Obstructive Lung Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0085581
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0600260
UMLS CUI [2,2]
C0205082
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Similar models

Eligibility Congestive Heart Failure NCT01965015

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is ≥ 18 and < 85 years old
boolean
C0001779 (UMLS CUI [1])
Ischemic cardiomyopathy chronic New York Heart Association Classification | Non-ischemic cardiomyopathy chronic New York Heart Association Classification | Heart failure Ambulatory New York Heart Association Classification | Therapy Optimal
Item
patient has chronic ischemic or non-ischemic cardiomyopathy nyha class iii or ambulatory class iv heart failure despite optimal medical therapy
boolean
C0349782 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0877438 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
C0018801 (UMLS CUI [3,1])
C0439841 (UMLS CUI [3,2])
C1275491 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C2698651 (UMLS CUI [4,2])
Left ventricular ejection fraction
Item
patient lvef > 15% and ≤ 40%
boolean
C0428772 (UMLS CUI [1])
Elevated left atrial pressure
Item
patient has elevated left atrial pressure (lap)
boolean
C4531219 (UMLS CUI [1])
Right atrial pressure Normal
Item
patient has normal right atrial pressure (rap)
boolean
C0456165 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Brain natriuretic peptide measurement | NT-proBNP Level
Item
bnp or ntprobnp levels are >300 or >1500 pg/ml, respectively
boolean
C1095989 (UMLS CUI [1])
C0754710 (UMLS CUI [2,1])
C0441889 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Heart Failure, Right-Sided
Item
right heart failure
boolean
C0235527 (UMLS CUI [1])
Malignant disease
Item
ongoing malignant disease
boolean
C0442867 (UMLS CUI [1])
Thromboembolism
Item
thromboembolic event within the last 6 months
boolean
C0040038 (UMLS CUI [1])
Renal Insufficiency | Chronic Kidney Insufficiency
Item
acute or chronic renal insufficiency
boolean
C1565489 (UMLS CUI [1])
C0403447 (UMLS CUI [2])
Congenital heart disease
Item
congenital heart disease
boolean
C0152021 (UMLS CUI [1])
Pulmonary Hypertension Severe
Item
severe pulmonary hypertension
boolean
C0020542 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Persistent atrial fibrillation | Permanent atrial fibrillation
Item
atrial fibrillation (persistent/permanent)
boolean
C2585653 (UMLS CUI [1])
C2586056 (UMLS CUI [2])
Mitral regurgitation Severe
Item
severe mitral regurgitation
boolean
C0026266 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Thrombus Arterial | Deep Vein Thrombosis
Item
la thrombus or deep vein thrombosis (dvt)
boolean
C0087086 (UMLS CUI [1,1])
C0221464 (UMLS CUI [1,2])
C0149871 (UMLS CUI [2])
Restrictive lung disease Severe | Obstructive Lung Disease Severe
Item
severe restrictive or obstructive lung disease
boolean
C0085581 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0600260 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
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