ID

39465

Description

Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study; ODM derived from: https://clinicaltrials.gov/show/NCT01627821

Link

https://clinicaltrials.gov/show/NCT01627821

Keywords

Versions (1)
  1. 1/13/20 1/13/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 13, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01627821

English

Eligibility Heart Failure NCT01627821

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. cardiac transplantation ineligible.
Description

Heart Transplantation Ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C1512714
2. late stage heart failure in nyha class iiib or iv for at least 45 of past 60 days.
Description

Heart failure Late stage New York Heart Association Classification | Heart failure Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1279941
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0449238
3. cardiac index < 2.2 l / min / m2
Description

Cardiac index

Data type

boolean

Alias
UMLS CUI [1]
C0428776
4. lvef = 25% or less
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
5. patients on optimal medical management (omm) as defined in section 9.2 or dependent on intra-aortic balloon counter-pulsation for 7 days or other temporary (indicated for 30 days use, or less) mechanical circulatory support for 7 days, or supported with iv inotropes for 7 days and failing to respond.
Description

Disease Management Optimal | Dependence Intra-aortic balloon counterpulsation | Dependence Mechanical Circulatory Support | Inotropic agent Left ventricle | Unresponsive to Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0376636
UMLS CUI [1,2]
C2698651
UMLS CUI [2,1]
C0439857
UMLS CUI [2,2]
C3826111
UMLS CUI [3,1]
C0439857
UMLS CUI [3,2]
C3274791
UMLS CUI [4,1]
C0304509
UMLS CUI [4,2]
C0225897
UMLS CUI [5]
C0205269
6. bsa > 1.2 m2 and < 2.5 m2.
Description

Body Surface Area

Data type

boolean

Alias
UMLS CUI [1]
C0005902
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of cardiac transplantation or left ventricular reduction procedure.
Description

Heart Transplantation | Ventricular reduction surgery Left sided

Data type

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2,1]
C1955770
UMLS CUI [2,2]
C0443246
2. clinical conditions, other than heart failure, which could limit survival to less than three years.
Description

Medical condition Limiting Survival | Exception Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0038952
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018801
3. cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis.
Description

Heart failure Etiology | Thyroid Diseases | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | Disorder of pericardium | Amyloidosis | Dermatomyositis | Myocarditis

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0015127
UMLS CUI [2]
C0040128
UMLS CUI [3]
C0007194
UMLS CUI [4]
C0007196
UMLS CUI [5]
C0265122
UMLS CUI [6]
C0002726
UMLS CUI [7]
C0011633
UMLS CUI [8]
C0027059
4. intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy.
Description

Intolerance to Anticoagulation Therapy | Intolerance to Platelet Aggregation Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0003281
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0032177
5. known sensitivity to products of bovine origin. the jarvik 2000 incorporates a hemashield vascular graft. patients with a known sensitivity to products of bovine origin should not be implanted.
Description

Hypersensitivity Bovine Product

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3667982
UMLS CUI [1,3]
C1254351
6. chronic immunosuppression.
Description

Immunosuppression chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C4048329
UMLS CUI [1,2]
C0205191
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Similar models

Eligibility Heart Failure NCT01627821

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Heart Transplantation Ineligible
Item
1. cardiac transplantation ineligible.
boolean
C0018823 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
Heart failure Late stage New York Heart Association Classification | Heart failure Duration
Item
2. late stage heart failure in nyha class iiib or iv for at least 45 of past 60 days.
boolean
C0018801 (UMLS CUI [1,1])
C1279941 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Cardiac index
Item
3. cardiac index < 2.2 l / min / m2
boolean
C0428776 (UMLS CUI [1])
Left ventricular ejection fraction
Item
4. lvef = 25% or less
boolean
C0428772 (UMLS CUI [1])
Disease Management Optimal | Dependence Intra-aortic balloon counterpulsation | Dependence Mechanical Circulatory Support | Inotropic agent Left ventricle | Unresponsive to Treatment
Item
5. patients on optimal medical management (omm) as defined in section 9.2 or dependent on intra-aortic balloon counter-pulsation for 7 days or other temporary (indicated for 30 days use, or less) mechanical circulatory support for 7 days, or supported with iv inotropes for 7 days and failing to respond.
boolean
C0376636 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0439857 (UMLS CUI [2,1])
C3826111 (UMLS CUI [2,2])
C0439857 (UMLS CUI [3,1])
C3274791 (UMLS CUI [3,2])
C0304509 (UMLS CUI [4,1])
C0225897 (UMLS CUI [4,2])
C0205269 (UMLS CUI [5])
Body Surface Area
Item
6. bsa > 1.2 m2 and < 2.5 m2.
boolean
C0005902 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Transplantation | Ventricular reduction surgery Left sided
Item
1. history of cardiac transplantation or left ventricular reduction procedure.
boolean
C0018823 (UMLS CUI [1])
C1955770 (UMLS CUI [2,1])
C0443246 (UMLS CUI [2,2])
Medical condition Limiting Survival | Exception Heart failure
Item
2. clinical conditions, other than heart failure, which could limit survival to less than three years.
boolean
C3843040 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0038952 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Heart failure Etiology | Thyroid Diseases | Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy | Disorder of pericardium | Amyloidosis | Dermatomyositis | Myocarditis
Item
3. cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis.
boolean
C0018801 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0040128 (UMLS CUI [2])
C0007194 (UMLS CUI [3])
C0007196 (UMLS CUI [4])
C0265122 (UMLS CUI [5])
C0002726 (UMLS CUI [6])
C0011633 (UMLS CUI [7])
C0027059 (UMLS CUI [8])
Intolerance to Anticoagulation Therapy | Intolerance to Platelet Aggregation Inhibitors
Item
4. intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy.
boolean
C1744706 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0032177 (UMLS CUI [2,2])
Hypersensitivity Bovine Product
Item
5. known sensitivity to products of bovine origin. the jarvik 2000 incorporates a hemashield vascular graft. patients with a known sensitivity to products of bovine origin should not be implanted.
boolean
C0020517 (UMLS CUI [1,1])
C3667982 (UMLS CUI [1,2])
C1254351 (UMLS CUI [1,3])
Immunosuppression chronic
Item
6. chronic immunosuppression.
boolean
C4048329 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
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