ID

16836

Beschreibung

EASYTRAK 4 Steerable LV Lead; ODM derived from: https://clinicaltrials.gov/show/NCT00158964

Link

https://clinicaltrials.gov/show/NCT00158964

Stichworte

Versionen (1)
  1. 09.08.16 09.08.16 -
Hochgeladen am

9. August 2016

DOI

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Creative Commons BY 4.0
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Eligibility Heart Failure NCT00158964

Englisch

Eligibility Heart Failure NCT00158964

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
must receive a commercially available guidant crt-p or crt-d device
Beschreibung

Cardiac Resynchronization Therapy Devices

Datentyp

boolean

Alias
UMLS CUI [1]
C2936377
creatinine < 2.5 mg/dl obtained no more than two weeks prior to enrollment
Beschreibung

Creatinine

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
age 18 or above, or of legal age to give informed consent specific to state and national law
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol
Beschreibung

Informed Consent, Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
geographically stable residents who are available for follow-up
Beschreibung

geographically stable residents who are available for follow-up

Datentyp

boolean

Alias
UMLS CUI [1]
C0017446
UMLS CUI [2]
C1321605
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a known hypersensitivity to a 1.0 mg (0.5 mg per electrode) nominal dose of dexamethasone acetate
Beschreibung

hypersensitivity to dexamethasone acetate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0057598
have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted lv lead placement
Beschreibung

previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted lv lead placement

Datentyp

boolean

Alias
UMLS CUI [1]
C1167956
UMLS CUI [2]
C3874606
UMLS CUI [3,1]
C2825199
UMLS CUI [3,2]
C1516084
have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads)
Beschreibung

Pre-existing cardioversion/defibrillation leads or right ventricular pacing leads

Datentyp

boolean

Alias
UMLS CUI [1]
C0162589
UMLS CUI [2,1]
C1283151
UMLS CUI [2,2]
C0225883
currently requiring dialysis
Beschreibung

Dialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011946
have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment
Beschreibung

myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C1532338
UMLS CUI [4]
C0010055
have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
Beschreibung

hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2]
C0264839
documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
Beschreibung

life expectancy of less than six months or expected to undergo heart transplant

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2]
C0018823
enrolled or participating in any concurrent study, including drug investigations, without guidant written approval, that may confound the results of this study
Beschreibung

enrolled or participating in any concurrent study that may confound the results of this study

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
have a pre-existing unipolar pacemaker that will not be explanted/abandoned
Beschreibung

pre-existing unipolar pacemaker

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C0443340
have a mechanical tricuspid heart valve
Beschreibung

mechanical tricuspid heart valve

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3873910
UMLS CUI [1,2]
C0040960
women who are pregnant or plan to become pregnant note: women of childbearing potential must have a negative pregnancy test within seven days of enrollment.
Beschreibung

Pregnancy Test

Datentyp

boolean

Alias
UMLS CUI [1]
C0032976
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Ähnliche Modelle

Eligibility Heart Failure NCT00158964

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Cardiac Resynchronization Therapy Devices
Item
must receive a commercially available guidant crt-p or crt-d device
boolean
C2936377 (UMLS CUI [1])
Creatinine
Item
creatinine < 2.5 mg/dl obtained no more than two weeks prior to enrollment
boolean
C0201976 (UMLS CUI [1])
Age
Item
age 18 or above, or of legal age to give informed consent specific to state and national law
boolean
C0001779 (UMLS CUI [1])
Informed Consent, Compliance
Item
willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
geographically stable residents who are available for follow-up
Item
geographically stable residents who are available for follow-up
boolean
C0017446 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
hypersensitivity to dexamethasone acetate
Item
have a known hypersensitivity to a 1.0 mg (0.5 mg per electrode) nominal dose of dexamethasone acetate
boolean
C0020517 (UMLS CUI [1,1])
C0057598 (UMLS CUI [1,2])
previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted lv lead placement
Item
have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted lv lead placement
boolean
C1167956 (UMLS CUI [1])
C3874606 (UMLS CUI [2])
C2825199 (UMLS CUI [3,1])
C1516084 (UMLS CUI [3,2])
Pre-existing cardioversion/defibrillation leads or right ventricular pacing leads
Item
have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads)
boolean
C0162589 (UMLS CUI [1])
C1283151 (UMLS CUI [2,1])
C0225883 (UMLS CUI [2,2])
Dialysis
Item
currently requiring dialysis
boolean
C0011946 (UMLS CUI [1])
myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft
Item
have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy
Item
have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
boolean
C0007194 (UMLS CUI [1])
C0264839 (UMLS CUI [2])
life expectancy of less than six months or expected to undergo heart transplant
Item
documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
boolean
C0023671 (UMLS CUI [1])
C0018823 (UMLS CUI [2])
enrolled or participating in any concurrent study that may confound the results of this study
Item
enrolled or participating in any concurrent study, including drug investigations, without guidant written approval, that may confound the results of this study
boolean
C2348568 (UMLS CUI [1])
pre-existing unipolar pacemaker
Item
have a pre-existing unipolar pacemaker that will not be explanted/abandoned
boolean
C0030163 (UMLS CUI [1,1])
C0443340 (UMLS CUI [1,2])
mechanical tricuspid heart valve
Item
have a mechanical tricuspid heart valve
boolean
C3873910 (UMLS CUI [1,1])
C0040960 (UMLS CUI [1,2])
Pregnancy Test
Item
women who are pregnant or plan to become pregnant note: women of childbearing potential must have a negative pregnancy test within seven days of enrollment.
boolean
C0032976 (UMLS CUI [1])
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