ID

39465

Beschrijving

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

Trefwoorden

Versies (1)
  1. 13-01-20 13-01-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

13 januari 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Heart Failure NCT01627821

Engels

Eligibility Heart Failure NCT01627821

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. cardiac transplantation ineligible.
Beschrijving

Heart Transplantation Ineligible

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Cardiac index

Datatype

boolean

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

Left ventricular ejection fraction

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Body Surface Area

Datatype

boolean

Alias
UMLS CUI [1]
C0005902
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Heart Transplantation | Ventricular reduction surgery Left sided

Datatype

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.
Beschrijving

Medical condition Limiting Survival | Exception Heart failure

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Intolerance to Anticoagulation Therapy | Intolerance to Platelet Aggregation Inhibitors

Datatype

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.
Beschrijving

Hypersensitivity Bovine Product

Datatype

boolean

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

Immunosuppression chronic

Datatype

boolean

Alias
UMLS CUI [1,1]
C4048329
UMLS CUI [1,2]
C0205191
Terug naar het begin van de pagina

Similar models

Eligibility Heart Failure NCT01627821

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial