ID

39391

Description

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

Keywords

  1. 1/6/20 1/6/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 6, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Heart Failure NCT01045343

Eligibility Heart Failure NCT01045343

Inclusion Criteria
Description

Inclusion Criteria

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

Informed Consent

Data type

boolean

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

Age

Data type

boolean

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

Protocol Compliance

Data type

boolean

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

Enrollment Network Specified

Data type

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
Description

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

Data type

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
Description

Implantation of CRT-D Specified

Data type

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
Description

Diuretic therapy Oral Daily | Management Heart failure

Data type

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
Description

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
Description

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

Data type

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
Description

Life Expectancy

Data type

boolean

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

CRT-D Battery Duration

Data type

boolean

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

Similar models

Eligibility Heart Failure NCT01045343

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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