ID

20859

Beschreibung

EASYTRAK 3 Downsize Lead; ODM derived from: https://clinicaltrials.gov/show/NCT00384722

Link

https://clinicaltrials.gov/show/NCT00384722

Stichworte

Versionen (1)
  1. 22.03.17 22.03.17 -
Hochgeladen am

22. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00384722

Englisch

Eligibility Heart Failure NCT00384722

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
must be indicated for a guidant crt-p or crt-d device
Beschreibung

Indication Cardiac Resynchronization Therapy Pacemaker (CRT-P) | Indication Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1737639
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1736558
creatinine < 2.5 mg/dl obtained no more than two weeks prior to enrollment
Beschreibung

Creatinine measurement, serum

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 | Device implant Willing | Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0948629
UMLS CUI [2,2]
C0600109
UMLS CUI [3]
C0525058
geographically stable residents who are available for follow-up
Beschreibung

Resident Stable geographical | Follow-up Resident Available

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347958
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0681784
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C2347958
UMLS CUI [2,3]
C0470187
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a known hypersensitivity to a 0.5 mg nominal dose of dexamethasone acetate
Beschreibung

Hypersensitivity Dexamethasone acetate Dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0057598
UMLS CUI [1,3]
C0178602
have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted lv lead placement
Beschreibung

Cardiac Resynchronization Therapy | Coronary venous pacing lead | Lead Placement Left ventricular Attempted

Datentyp

boolean

Alias
UMLS CUI [1]
C1167956
UMLS CUI [2]
C3874606
UMLS CUI [3,1]
C2346652
UMLS CUI [3,2]
C0225897
UMLS CUI [3,3]
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

Electric Countershock Leads Pre-existing | Pacing Leads Right ventricular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013778
UMLS CUI [1,2]
C0181586
UMLS CUI [1,3]
C2347662
UMLS CUI [2,1]
C1285520
UMLS CUI [2,2]
C0181586
UMLS CUI [2,3]
C0225883
currently requiring dialysis
Beschreibung

Dialysis Patient need for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0686904
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 Infarction | Angina, Unstable | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

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 Cardiomyopathy | Restrictive cardiomyopathy secondary to infiltrations | Amyloidosis | Sarcoidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2]
C0264839
UMLS CUI [3]
C0002726
UMLS CUI [4]
C0036202
documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
Beschreibung

Life Expectancy | Heart Transplantation Expected

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0018823
UMLS CUI [2,2]
C1517001
enrolled or participating in any concurrent study, including drug investigations, without guidant written approval, that may confound the results of this study
Beschreibung

Study Subject Participation Status Interferes with Research results | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2]
C0013230
have a pre-existing unipolar pacemaker that will not be explanted/abandoned
Beschreibung

Artificial cardiac pacemaker Unipolar Pre-existing | Explantation Missing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C0443340
UMLS CUI [1,3]
C2347662
UMLS CUI [2,1]
C0561946
UMLS CUI [2,2]
C1705492
have a mechanical tricuspid heart valve
Beschreibung

heart - tricuspid valve

Datentyp

boolean

Alias
UMLS CUI [1]
C0869757
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 | Pregnancy, Planned | Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
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Ähnliche Modelle

Eligibility Heart Failure NCT00384722

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Indication Cardiac Resynchronization Therapy Pacemaker (CRT-P) | Indication Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Item
must be indicated for a guidant crt-p or crt-d device
boolean
C3146298 (UMLS CUI [1,1])
C1737639 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C1736558 (UMLS CUI [2,2])
Creatinine measurement, serum
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 | Device implant Willing | Protocol 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])
C0948629 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3])
Resident Stable geographical | Follow-up Resident Available
Item
geographically stable residents who are available for follow-up
boolean
C2347958 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0681784 (UMLS CUI [1,3])
C3274571 (UMLS CUI [2,1])
C2347958 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Dexamethasone acetate Dose
Item
have a known hypersensitivity to a 0.5 mg nominal dose of dexamethasone acetate
boolean
C0020517 (UMLS CUI [1,1])
C0057598 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Cardiac Resynchronization Therapy | Coronary venous pacing lead | Lead Placement Left ventricular Attempted
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])
C2346652 (UMLS CUI [3,1])
C0225897 (UMLS CUI [3,2])
C1516084 (UMLS CUI [3,3])
Electric Countershock Leads Pre-existing | Pacing Leads Right ventricular
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
C0013778 (UMLS CUI [1,1])
C0181586 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C1285520 (UMLS CUI [2,1])
C0181586 (UMLS CUI [2,2])
C0225883 (UMLS CUI [2,3])
Dialysis Patient need for
Item
currently requiring dialysis
boolean
C0011946 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Myocardial Infarction | Angina, Unstable | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
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 Cardiomyopathy | Restrictive cardiomyopathy secondary to infiltrations | Amyloidosis | Sarcoidosis
Item
have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
boolean
C0007194 (UMLS CUI [1])
C0264839 (UMLS CUI [2])
C0002726 (UMLS CUI [3])
C0036202 (UMLS CUI [4])
Life Expectancy | Heart Transplantation Expected
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 [2,1])
C1517001 (UMLS CUI [2,2])
Study Subject Participation Status Interferes with Research results | Investigational New Drugs
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 [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2])
Artificial cardiac pacemaker Unipolar Pre-existing | Explantation Missing
Item
have a pre-existing unipolar pacemaker that will not be explanted/abandoned
boolean
C0030163 (UMLS CUI [1,1])
C0443340 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0561946 (UMLS CUI [2,1])
C1705492 (UMLS CUI [2,2])
heart - tricuspid valve
Item
have a mechanical tricuspid heart valve
boolean
C0869757 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned | Childbearing Potential Pregnancy test negative
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
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
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