ID

39391

Descripción

Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01045343

Link

https://clinicaltrials.gov/show/NCT01045343

Palabras clave

Versiones (1)
  1. 6/1/20 6/1/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

6 de enero de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01045343

Inglés

Eligibility Heart Failure NCT01045343

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is willing and able to provide written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
subject is at least 18 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
subject is willing and able to comply with the clinical investigation plan
Descripción

Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
subject is currently enrolled in the medtronic carelink® network
Descripción

Enrollment Network Specified

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C1882071
UMLS CUI [1,3]
C0205369
subject is currently a new heart association (nyha) functional class iii or nyha functional class ii with a heart failure related hospitalization within the past 180 days
Descripción

Heart failure New York Heart Association Classification | Hospitalization Due to Heart Failure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C3898876
subject has a medtronic concerto®/consulta® cardiac resynchronization therapy (crt)device implanted for at least 180 days
Descripción

Implantation of CRT-D Specified

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1135480
UMLS CUI [1,2]
C0205369
subject has been prescribed daily oral diuretic therapy for the management of heart failure
Descripción

Diuretic therapy Oral Daily | Management Heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0948575
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0332173
UMLS CUI [2,1]
C0376636
UMLS CUI [2,2]
C0018801
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject is enrolled in a concurrent study with the exception of a study approved by the indicate hf clinical trial leader
Descripción

Study Subject Participation Status | Clinical Trial | Exception Clinical Trial Approved

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0008976
UMLS CUI [3,3]
C0205540
subject has a life expectancy of less than 1 year
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
subject's crt device has an estimated battery life of less than 2 years
Descripción

CRT-D Battery Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1135480
UMLS CUI [1,2]
C1704779
UMLS CUI [1,3]
C0449238
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Similar models

Eligibility Heart Failure NCT01045343

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
subject is willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
subject is at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
subject is willing and able to comply with the clinical investigation plan
boolean
C0525058 (UMLS CUI [1])
Enrollment Network Specified
Item
subject is currently enrolled in the medtronic carelink® network
boolean
C1516879 (UMLS CUI [1,1])
C1882071 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Heart failure New York Heart Association Classification | Hospitalization Due to Heart Failure
Item
subject is currently a new heart association (nyha) functional class iii or nyha functional class ii with a heart failure related hospitalization within the past 180 days
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C3898876 (UMLS CUI [2])
Implantation of CRT-D Specified
Item
subject has a medtronic concerto®/consulta® cardiac resynchronization therapy (crt)device implanted for at least 180 days
boolean
C1135480 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Diuretic therapy Oral Daily | Management Heart failure
Item
subject has been prescribed daily oral diuretic therapy for the management of heart failure
boolean
C0948575 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0376636 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Clinical Trial | Exception Clinical Trial Approved
Item
subject is enrolled in a concurrent study with the exception of a study approved by the indicate hf clinical trial leader
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
C0205540 (UMLS CUI [3,3])
Life Expectancy
Item
subject has a life expectancy of less than 1 year
boolean
C0023671 (UMLS CUI [1])
CRT-D Battery Duration
Item
subject's crt device has an estimated battery life of less than 2 years
boolean
C1135480 (UMLS CUI [1,1])
C1704779 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
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