Informações:
Falhas:
ID
39400
Descrição
EVAHEART LVAS Bridge-to-Transplant Pivotal Study; ODM derived from: https://clinicaltrials.gov/show/NCT01187368
Link
https://clinicaltrials.gov/show/NCT01187368
Palavras-chave
Versões (1)
- 07/01/2020 07/01/2020 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
7 de janeiro de 2020
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Heart Failure NCT01187368
Eligibility Heart Failure NCT01187368
- StudyEvent: Eligibility
Similar models
Eligibility Heart Failure NCT01187368
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Inclusion criteria General
Item
the following is a list of general inclusion criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
C0205246 (UMLS CUI [1,2])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Patient on waiting list Heart Transplantation | Waiting list status
Item
listed for cardiac transplant as a status 1a or 1b
boolean
C0422768 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
C0586018 (UMLS CUI [2])
C0018823 (UMLS CUI [1,2])
C0586018 (UMLS CUI [2])
Heart failure New York Heart Association Classification
Item
nyha class iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,2])
Informed Consent
Item
patient is able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Inclusion criteria Study Protocol
Item
more detailed inclusion criteria information is noted in the study protocol
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
Exclusion Criteria General
Item
the following is a list of general exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
C0205246 (UMLS CUI [1,2])
Communicable Disease Uncontrolled
Item
active, uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,2])
Body Surface Area
Item
bsa < 1.4 m²
boolean
C0005902 (UMLS CUI [1])
Organ failure
Item
irreversible organ failure
boolean
C0349410 (UMLS CUI [1])
Right ventricular failure Severe
Item
severe right ventricular failure
boolean
C2939447 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
Mechanical Aortic Valve | Mechanical Mitral Valve
Item
prosthetic mechanical aortic or mitral valve
boolean
C2825203 (UMLS CUI [1])
C2825205 (UMLS CUI [2])
C2825205 (UMLS CUI [2])
Implantation of left ventricular assist device At risk | Left ventricular assist device Maintenance At risk
Item
patients with an unacceptable risk for successful lvad implantation and maintenance
boolean
C0397130 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0181598 (UMLS CUI [2,1])
C0024501 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C1444641 (UMLS CUI [1,2])
C0181598 (UMLS CUI [2,1])
C0024501 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Transfusion blood refusal
Item
patients refusing blood transfusion
boolean
C0749628 (UMLS CUI [1])
Intolerant Anticoagulation Therapy
Item
intolerant of anticoagulation therapy
boolean
C0231200 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0003281 (UMLS CUI [1,2])
Blood Coagulation Disorder
Item
coagulopathy
boolean
C0005779 (UMLS CUI [1])
Mental disorder Impairing Protocol Compliance | Cognitive dysfunction Impairing Protocol Compliance | Psychosocial Factors Impairing Protocol Compliance
Item
active psychiatric disorder, irreversible cognitive dysfunction or other psychosocial behavior that impairs the ability of the patient to follow instructions, maintain their device or their medical regimen
boolean
C0004936 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0338656 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0033963 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0221099 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0338656 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0033963 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Patient need for Mechanical Circulatory Support Device | Exception Intra-Aortic Balloon Pump
Item
current dependence on other mechanical circulatory support device at the time of implant, other than iabp
boolean
C0686904 (UMLS CUI [1,1])
C3274791 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0021860 (UMLS CUI [2,2])
C3274791 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0021860 (UMLS CUI [2,2])
Condition Limiting Survival | Exception Heart failure
Item
presence of condition other than heart failure that would limit survival to less than 3 years
boolean
C0348080 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0038952 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C0439801 (UMLS CUI [1,2])
C0038952 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Exclusion Criteria Study Protocol
Item
more detailed exclusion criteria information is noted in the study protocol
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])