ID

16955

Beschrijving

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

Trefwoorden

  1. 15-08-16 15-08-16 -
  2. 16-08-16 16-08-16 - Julian Varghese
Geüploaded op

16 augustus 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Heart Failure, Congestive NCT00400985

Eligibility Heart Failure, Congestive NCT00400985

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

insync sentry device

Datatype

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
Beschrijving

hospitalization for heart failure that required administration of iv medication

Datatype

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
Beschrijving

Transvenous, high voltage rv lead

Datatype

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
Beschrijving

Subject is able to detect a patient alert signal

Datatype

boolean

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

Exclusion Criteria

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

Age

Datatype

boolean

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

COPD

Datatype

boolean

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

Heart transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0018823
primary pulmonary hypertension
Beschrijving

Primary pulmonary hypertension

Datatype

boolean

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

Dialysis

Datatype

boolean

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

Amendment to the Inclusion Criteria (Jul 06):

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

patients with concerto/virtuoso devices

Datatype

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
Beschrijving

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

Datatype

boolean

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

Similar models

Eligibility Heart Failure, Congestive NCT00400985

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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