ID

15186

Description

CardioMEMS HF System Post Approval Study; ODM derived from: https://clinicaltrials.gov/show/NCT02279888

Link

https://clinicaltrials.gov/show/NCT02279888

Keywords

Versions (1)
  1. 5/21/16 5/21/16 -
Uploaded on

May 21, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02279888

English

Eligibility Heart Failure NCT02279888

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of nyha class iii heart failure
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
at least 1 heart failure hospitalization within previous 12 months
Description

Hospitalization Due to Heart Failure

Data type

boolean

Alias
UMLS CUI [1]
C3898876
patients with reduced lvef heart failure should be receiving a beta blocker for 3 months and an ace-i or arb for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ace-i or arb
Description

Heart failure | Left ventricular ejection fraction Reduced | Adrenergic beta-Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Intolerance Adrenergic beta-Antagonists | Intolerance Angiotensin-Converting Enzyme Inhibitors | Intolerance Angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0428772
UMLS CUI [1,3]
C0392756
UMLS CUI [2]
C0001645
UMLS CUI [3]
C0003015
UMLS CUI [4]
C0521942
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0001645
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0003015
UMLS CUI [7,1]
C1744706
UMLS CUI [7,2]
C0521942
bmi ≤ 35. patients with bmi >35 will require their chest circumference to be measured at the axillary level. if > 65 inches the patient will not be eligible for the study.
Description

Body mass index | Measurement of chest circumference Axilla

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2,1]
C4039710
UMLS CUI [2,2]
C0004454
pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)
Description

Pulmonary artery branch Diameter | Implant Target Artery | Catheterization of right heart

Data type

boolean

Alias
UMLS CUI [1,1]
C1282007
UMLS CUI [1,2]
C1301886
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0003842
UMLS CUI [3]
C0189896
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active infection
Description

Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0009450
history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
Description

Recurrent pulmonary embolism | Deep Vein Thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C1735914
UMLS CUI [2]
C0149871
inability to tolerate a right heart catheterization
Description

Catheterization of right heart Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0189896
UMLS CUI [1,2]
C1299582
a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
Description

Cardiovascular event Major | Thallium stress test | Open heart surgery | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C1455714
UMLS CUI [3]
C0189745
UMLS CUI [4]
C0038454
cardiac resynchronization device (crt) implanted within previous 3 months
Description

Implantation procedure Cardiac Resynchronization Therapy Devices

Data type

boolean

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C2936377
glomerular filtration rate (gfr) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
Description

Glomerular Filtration Rate | Implantation procedure | Responsive to Diuretic therapy | H/O: renal dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0017654
UMLS CUI [2]
C0021107
UMLS CUI [3,1]
C1833335
UMLS CUI [3,2]
C0948575
UMLS CUI [4]
C0455667
congenital heart disease or mechanical right heart valve
Description

Congenital heart disease | MECHANICAL HEART-VALVE Right

Data type

boolean

Alias
UMLS CUI [1]
C0152021
UMLS CUI [2,1]
C0493527
UMLS CUI [2,2]
C0205090
likely to undergo heart transplantation or vad within the next 6 months
Description

Heart Transplantation | Artificial Ventricle

Data type

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2]
C0085842
known coagulation disorders
Description

Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779
hypersensitivity or allergy to aspirin, and/or clopidogrel
Description

Hypersensitivity Aspirin | Hypersensitivity clopidogrel

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0070166
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Similar models

Eligibility Heart Failure NCT02279888

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
New York Heart Association Classification
Item
diagnosis of nyha class iii heart failure
boolean
C1275491 (UMLS CUI [1])
Hospitalization Due to Heart Failure
Item
at least 1 heart failure hospitalization within previous 12 months
boolean
C3898876 (UMLS CUI [1])
Heart failure | Left ventricular ejection fraction Reduced | Adrenergic beta-Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Intolerance Adrenergic beta-Antagonists | Intolerance Angiotensin-Converting Enzyme Inhibitors | Intolerance Angiotensin II receptor antagonist
Item
patients with reduced lvef heart failure should be receiving a beta blocker for 3 months and an ace-i or arb for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ace-i or arb
boolean
C0018801 (UMLS CUI [1,1])
C0428772 (UMLS CUI [1,2])
C0392756 (UMLS CUI [1,3])
C0001645 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
C1744706 (UMLS CUI [5,1])
C0001645 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0003015 (UMLS CUI [6,2])
C1744706 (UMLS CUI [7,1])
C0521942 (UMLS CUI [7,2])
Body mass index | Measurement of chest circumference Axilla
Item
bmi ≤ 35. patients with bmi >35 will require their chest circumference to be measured at the axillary level. if > 65 inches the patient will not be eligible for the study.
boolean
C1305855 (UMLS CUI [1])
C4039710 (UMLS CUI [2,1])
C0004454 (UMLS CUI [2,2])
Pulmonary artery branch Diameter | Implant Target Artery | Catheterization of right heart
Item
pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)
boolean
C1282007 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0021102 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0003842 (UMLS CUI [2,3])
C0189896 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Communicable Diseases
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Recurrent pulmonary embolism | Deep Vein Thrombosis
Item
history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
boolean
C1735914 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
Catheterization of right heart Unable
Item
inability to tolerate a right heart catheterization
boolean
C0189896 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Cardiovascular event Major | Thallium stress test | Open heart surgery | Cerebrovascular accident
Item
a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1455714 (UMLS CUI [2])
C0189745 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
Implantation procedure Cardiac Resynchronization Therapy Devices
Item
cardiac resynchronization device (crt) implanted within previous 3 months
boolean
C0021107 (UMLS CUI [1,1])
C2936377 (UMLS CUI [1,2])
Glomerular Filtration Rate | Implantation procedure | Responsive to Diuretic therapy | H/O: renal dialysis
Item
glomerular filtration rate (gfr) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
boolean
C0017654 (UMLS CUI [1])
C0021107 (UMLS CUI [2])
C1833335 (UMLS CUI [3,1])
C0948575 (UMLS CUI [3,2])
C0455667 (UMLS CUI [4])
Congenital heart disease | MECHANICAL HEART-VALVE Right
Item
congenital heart disease or mechanical right heart valve
boolean
C0152021 (UMLS CUI [1])
C0493527 (UMLS CUI [2,1])
C0205090 (UMLS CUI [2,2])
Heart Transplantation | Artificial Ventricle
Item
likely to undergo heart transplantation or vad within the next 6 months
boolean
C0018823 (UMLS CUI [1])
C0085842 (UMLS CUI [2])
Blood Coagulation Disorders
Item
known coagulation disorders
boolean
C0005779 (UMLS CUI [1])
Hypersensitivity Aspirin | Hypersensitivity clopidogrel
Item
hypersensitivity or allergy to aspirin, and/or clopidogrel
boolean
C0020517 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
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