ID

16955

Description

Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00400985

Link

https://clinicaltrials.gov/show/NCT00400985

Keywords

Versions (2)
  1. 8/15/16 8/15/16 -
  2. 8/16/16 8/16/16 - Julian Varghese
Uploaded on

August 16, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure, Congestive NCT00400985

English

Eligibility Heart Failure, Congestive NCT00400985

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
successfully implanted insync sentry device (< 34 days post implant or pocket revision)in the pectoral region;
Description

insync sentry device

Data type

boolean

Alias
UMLS CUI [1]
C1135480
at least one hf-related hospitalization that required administration of iv medication (inotropes, nitrates, diuretics) within the last 12 months
Description

hospitalization for heart failure that required administration of iv medication

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2,1]
C0304509
UMLS CUI [2,2]
C0348016
UMLS CUI [3,1]
C0012798
UMLS CUI [3,2]
C0348016
UMLS CUI [4,1]
C0017887
UMLS CUI [4,2]
C0348016
the subject has a market released, transvenous, high voltage rv lead
Description

Transvenous, high voltage rv lead

Data type

boolean

Alias
UMLS CUI [1,1]
C2048371
UMLS CUI [1,2]
C0336575
UMLS CUI [1,3]
C0337034
the subject is able to detect a patient alert signal
Description

Subject is able to detect a patient alert signal

Data type

boolean

Alias
UMLS CUI [1,1]
C1511790
UMLS CUI [1,2]
C2347453
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
<18 years of age (or under a minimum age required by local law)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
moderate to severe chronic obstructive pulmonary disease (copd)
Description

COPD

Data type

boolean

Alias
UMLS CUI [1]
C0024117
post heart transplant or awaiting heart transplantation
Description

Heart transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0018823
primary pulmonary hypertension
Description

Primary pulmonary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0152171
renal insufficiency requiring dialysis
Description

Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0011946
Amendment to the Inclusion Criteria (Jul 06):
Description

Amendment to the Inclusion Criteria (Jul 06):

Alias
UMLS CUI-1
C1512693
inclusion of patients with concerto/virtuoso devices.
Description

patients with concerto/virtuoso devices

Data type

boolean

at least one hf-related hospitalization that required administration of iv (or uptitration of the oral medication)(inotropes, nitrates, diuretics)within the last 12 months
Description

Heart failure-related hospitalization that required administration of iv or uptitration of the oral medication

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0304509
UMLS CUI [3]
C0012798
UMLS CUI [4]
C0017887
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Similar models

Eligibility Heart Failure, Congestive NCT00400985

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
insync sentry device
Item
successfully implanted insync sentry device (< 34 days post implant or pocket revision)in the pectoral region;
boolean
C1135480 (UMLS CUI [1])
hospitalization for heart failure that required administration of iv medication
Item
at least one hf-related hospitalization that required administration of iv medication (inotropes, nitrates, diuretics) within the last 12 months
boolean
C0018801 (UMLS CUI [1])
C0304509 (UMLS CUI [2,1])
C0348016 (UMLS CUI [2,2])
C0012798 (UMLS CUI [3,1])
C0348016 (UMLS CUI [3,2])
C0017887 (UMLS CUI [4,1])
C0348016 (UMLS CUI [4,2])
Transvenous, high voltage rv lead
Item
the subject has a market released, transvenous, high voltage rv lead
boolean
C2048371 (UMLS CUI [1,1])
C0336575 (UMLS CUI [1,2])
C0337034 (UMLS CUI [1,3])
Subject is able to detect a patient alert signal
Item
the subject is able to detect a patient alert signal
boolean
C1511790 (UMLS CUI [1,1])
C2347453 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
<18 years of age (or under a minimum age required by local law)
boolean
C0001779 (UMLS CUI [1])
COPD
Item
moderate to severe chronic obstructive pulmonary disease (copd)
boolean
C0024117 (UMLS CUI [1])
Heart transplantation
Item
post heart transplant or awaiting heart transplantation
boolean
C0018823 (UMLS CUI [1])
Primary pulmonary hypertension
Item
primary pulmonary hypertension
boolean
C0152171 (UMLS CUI [1])
Dialysis
Item
renal insufficiency requiring dialysis
boolean
C0011946 (UMLS CUI [1])
Item Group
Amendment to the Inclusion Criteria (Jul 06):
C1512693 (UMLS CUI-1)
patients with concerto/virtuoso devices
Item
inclusion of patients with concerto/virtuoso devices.
boolean
Heart failure-related hospitalization that required administration of iv or uptitration of the oral medication
Item
at least one hf-related hospitalization that required administration of iv (or uptitration of the oral medication)(inotropes, nitrates, diuretics)within the last 12 months
boolean
C0018801 (UMLS CUI [1])
C0304509 (UMLS CUI [2])
C0012798 (UMLS CUI [3])
C0017887 (UMLS CUI [4])
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