ID

39477

Description

Integrated Diagnostic for Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01798797

Link

https://clinicaltrials.gov/show/NCT01798797

Keywords

Versions (1)
  1. 1/15/20 1/15/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 15, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01798797

English

Eligibility Heart Failure NCT01798797

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is 18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient ( or patient's legally authorized representative) is willing and able to provide written informed consent
Description

Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
patient is willing and able to comply with the required study follow up visits
Description

Compliance behavior Follow-up visit

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0589121
patient is implanted with a medtronic wireless icd or crt-d device capable of optivol fluid monitoring feature
Description

Implantable defibrillator insertion | Implantation of CRT-D | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C0877213
UMLS CUI [2]
C1135480
UMLS CUI [3]
C3846158
patient is on medtronic carelink network or is willing to be enrolled on the 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
patient is being managed, or has been managed, by a hf clinician
Description

Disease Management Heart failure Clinician

Data type

boolean

Alias
UMLS CUI [1,1]
C0376636
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C0871685
patient has signed an informed consent for carelink network services
Description

Informed Consent Network Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1882071
UMLS CUI [1,3]
C0205369
patient is implanted with device for at least three months
Description

Implanted device

Data type

boolean

Alias
UMLS CUI [1]
C0021102
patient is willing and able to transmit data using the carelink home monitor (2490c).
Description

Use of Monitor Specified | Data Transmission

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0181904
UMLS CUI [1,3]
C0205369
UMLS CUI [2]
C0332289
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is participating in another study that may interfere with triage-hf protocol required procedures
Description

Study Subject Participation Status | Clinical Trial Interferes with Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
patient with an implantable cardiac device that is indicated to reach eri in less than 12 months
Description

Cardiac implant device Problem

Data type

boolean

Alias
UMLS CUI [1,1]
C0581396
UMLS CUI [1,2]
C0033213
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Similar models

Eligibility Heart Failure NCT01798797

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative
Item
patient ( or patient's legally authorized representative) is willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Compliance behavior Follow-up visit
Item
patient is willing and able to comply with the required study follow up visits
boolean
C1321605 (UMLS CUI [1,1])
C0589121 (UMLS CUI [1,2])
Implantable defibrillator insertion | Implantation of CRT-D | Other Coding
Item
patient is implanted with a medtronic wireless icd or crt-d device capable of optivol fluid monitoring feature
boolean
C0877213 (UMLS CUI [1])
C1135480 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
Enrollment Network Specified
Item
patient is on medtronic carelink network or is willing to be enrolled on the carelink network
boolean
C1516879 (UMLS CUI [1,1])
C1882071 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Disease Management Heart failure Clinician
Item
patient is being managed, or has been managed, by a hf clinician
boolean
C0376636 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0871685 (UMLS CUI [1,3])
Informed Consent Network Specified
Item
patient has signed an informed consent for carelink network services
boolean
C0021430 (UMLS CUI [1,1])
C1882071 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Implanted device
Item
patient is implanted with device for at least three months
boolean
C0021102 (UMLS CUI [1])
Use of Monitor Specified | Data Transmission
Item
patient is willing and able to transmit data using the carelink home monitor (2490c).
boolean
C1524063 (UMLS CUI [1,1])
C0181904 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0332289 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Clinical Trial Interferes with Protocol Compliance
Item
patient is participating in another study that may interfere with triage-hf protocol required procedures
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Cardiac implant device Problem
Item
patient with an implantable cardiac device that is indicated to reach eri in less than 12 months
boolean
C0581396 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
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