ID

40866

Description

Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures; ODM derived from: https://clinicaltrials.gov/show/NCT01370564

Link

https://clinicaltrials.gov/show/NCT01370564

Keywords

Versions (1)
  1. 5/27/20 5/27/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 27, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01370564

English

Eligibility Heart Failure NCT01370564

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients implanted with a chronicle ihm device (model 9520, model 9520b) or chronicle icd device (model 7286)
Description

Implantable Hemodynamic Monitor chronic | Implantable defibrillator chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C4082936
UMLS CUI [1,2]
C0021102
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C0205191
patients who have been prescribed daily diuretic therapy for the management of heart failure
Description

Diuretic therapy Daily Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0948575
UMLS CUI [1,2]
C0332173
UMLS CUI [1,3]
C0018801
patients currently participating in the compass-hf extension phase study (ide
Description

Study Subject Participation Status | Heart failure Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205369
#g020304)
Description

ID.4

Data type

boolean

patients willing and able to give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with non-physiologic right ventricular (rv) pressure values
Description

Right ventricular pressure Abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0456166
UMLS CUI [1,2]
C0205161
patients who have diuretic resistance
Description

Patients Resistant to Diuretics

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C0012798
patients who have an estimated glomerular filtration rate(egfr) <30 ml/min (recorded within the last six months)
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
patients who have a chronicle ihm device (model 9520) that was implanted as part of the pulmonary arterial hypertension (pah) pilot study (ide #g020303)
Description

Implantable Hemodynamic Monitor chronic | Relationship Pulmonary arterial hypertension Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C4082936
UMLS CUI [1,2]
C0021102
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C2973725
UMLS CUI [2,3]
C0008976
patients who do not have the ability to actively participate in the management of their own heart failure care (determine by physician discretion)(e.g. patient does not have ability to operate study equipment, patient does not have a history of compliance to sending carelink transmissions)
Description

Heart failure Disease Management Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0376636
UMLS CUI [1,3]
C1299582
patients who have a reasonable probability of needing a device replacement during the study (approximately two months)
Description

Patient need for Replacement of device

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C1446530
patients enrolled or planning to participate in a concurrent drug and/or device study during the course of this clinical trial
Description

Study Subject Participation Status | Research study | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0681814
UMLS CUI [3]
C0013230
UMLS CUI [4]
C2346570
patient who are pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
Description

Pregnancy | Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
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Similar models

Eligibility Heart Failure NCT01370564

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Implantable Hemodynamic Monitor chronic | Implantable defibrillator chronic
Item
patients implanted with a chronicle ihm device (model 9520, model 9520b) or chronicle icd device (model 7286)
boolean
C4082936 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0162589 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Diuretic therapy Daily Heart failure
Item
patients who have been prescribed daily diuretic therapy for the management of heart failure
boolean
C0948575 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Study Subject Participation Status | Heart failure Clinical Trial Specified
Item
patients currently participating in the compass-hf extension phase study (ide
boolean
C2348568 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
ID.4
Item
#g020304)
boolean
Informed Consent
Item
patients willing and able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Right ventricular pressure Abnormal
Item
patients with non-physiologic right ventricular (rv) pressure values
boolean
C0456166 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Patients Resistant to Diuretics
Item
patients who have diuretic resistance
boolean
C0030705 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0012798 (UMLS CUI [1,3])
Estimated Glomerular Filtration Rate
Item
patients who have an estimated glomerular filtration rate(egfr) <30 ml/min (recorded within the last six months)
boolean
C3811844 (UMLS CUI [1])
Implantable Hemodynamic Monitor chronic | Relationship Pulmonary arterial hypertension Clinical Trial
Item
patients who have a chronicle ihm device (model 9520) that was implanted as part of the pulmonary arterial hypertension (pah) pilot study (ide #g020303)
boolean
C4082936 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0439849 (UMLS CUI [2,1])
C2973725 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Heart failure Disease Management Unable
Item
patients who do not have the ability to actively participate in the management of their own heart failure care (determine by physician discretion)(e.g. patient does not have ability to operate study equipment, patient does not have a history of compliance to sending carelink transmissions)
boolean
C0018801 (UMLS CUI [1,1])
C0376636 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Patient need for Replacement of device
Item
patients who have a reasonable probability of needing a device replacement during the study (approximately two months)
boolean
C0686904 (UMLS CUI [1,1])
C1446530 (UMLS CUI [1,2])
Study Subject Participation Status | Research study | Investigational New Drugs | Investigational Medical Device
Item
patients enrolled or planning to participate in a concurrent drug and/or device study during the course of this clinical trial
boolean
C2348568 (UMLS CUI [1])
C0681814 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C2346570 (UMLS CUI [4])
Pregnancy | Childbearing Potential Pregnancy test negative
Item
patient who are pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
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