ID

43430

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00729235

Link

http://clinicaltrials.gov/show/NCT00729235

Stichworte

Versionen (3)
  1. 06.12.13 06.12.13 - Martin Dugas
  2. 16.04.14 16.04.14 - Julian Varghese
  3. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility NCT00729235 Biventricular Tachycardias

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beschreibung

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Beschreibung

age at least 18 Years

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Biventricular Tachycardias
Beschreibung

Biventricular Tachycardias

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0042514
SNOMED CT 2011_0131
25569003
MedDRA 14.1
10047302
ICD-10-CM Version 2010
I47.2
CTCAE 1105E
E10239
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Patient has been prescribed the implantation or replacement of a CRT-ICD system accordingly to the relevant currently-approved ACC/AHA15 (August 2005, Appendix § M.10) or ESC 16 (Update 2005, Appendix § M.11) guidelines or any relevant currently-approved local guidelines for the implantation or replacement of CRT-ICD.
Beschreibung

Patient has been prescribed the implantation or replacement of a CRT-ICD system accordingly to the relevant currently-approved ACC/AHA15 (August 2005, Appendix § M.10) or ESC 16 (Update 2005, Appendix § M.11) guidelines or any relevant currently-approved local guidelines for the implantation or replacement of CRT-ICD.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0033080
SNOMED CT 2011_0131
16076005
UMLS CUI 2011AA
C0021107
SNOMED CT 2011_0131
71861002
LOINC Version 232
MTHU035917
UMLS CUI 2011AA
C0559956
SNOMED CT 2011_0131
282089006
UMLS CUI 2011AA
C2936377
UMLS CUI 2011AA
C0162589
SNOMED CT 2011_0131
72506001
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0205540
SNOMED CT 2011_0131
9571008
UMLS CUI 2011AA
C0220845
Patient's Signature on Informed Consent Form
Beschreibung

Patient has signed a consent form after he/she received the appropriate and mandatory information.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2348583
Ausschlusskriterien
Beschreibung

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Clinical history of symptomatic or not symptomatic slow VT
Beschreibung

Clinical history of symptomatic or not symptomatic slow VT

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0021430
permanentes Vorhofflimmern
Beschreibung

Permanent Atrial Fibrillation (AF)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2586056
SNOMED CT 2011_0131
440028005
MedDRA 14.1
10071668
Any contraindication to the implant or replacement of CRT-ICD
Beschreibung

Any contraindication to the implant or replacement of CRT-ICD

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0021107
SNOMED CT 2011_0131
71861002
LOINC Version 232
MTHU035917
UMLS CUI 2011AA
C0559956
SNOMED CT 2011_0131
282089006
UMLS CUI 2011AA
C2936377
UMLS CUI 2011AA
C0162589
SNOMED CT 2011_0131
72506001
Pt is unable to attend the scheduled f-up visits at the implanting Centre
Beschreibung

Pt is unable to attend the scheduled f-up visits at the implanting Centre

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C0589121
SNOMED CT 2011_0131
185389009
Pt is already included in another ongoing clinical study
Beschreibung

Pt is already included in another ongoing clinical study

Datentyp

boolean

Alias
UMLS CUI 2011AA
C2348568
Pt is unable to understand the objectives of the ITAC04 study
Beschreibung

Pt is unable to understand the objectives of the ITAC04 study

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0162340
SNOMED CT 2011_0131
66216009
UMLS CUI 2011AA
C0681832
Pt refuses to cooperate
Beschreibung

Pt refuses to cooperate

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0392337
UMLS CUI 2011AA
C1705116
SNOMED CT 2011_0131
443390004
Pt is unable or refuses to provide informed consent
Beschreibung

Pt is unable or refuses to provide informed consent

Datentyp

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C1705116
SNOMED CT 2011_0131
443390004
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
Minderjähriger
Beschreibung

Pt is minor (less than 18-year old)

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0026193
SNOMED CT 2011_0131
410599005
Pt has life expectancy of less than 1 year
Beschreibung

Pt has life expectancy of less than 1 year

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0021430
Pt is pregnant.
Beschreibung

Pt is pregnant.

Datentyp

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Biventricular Tachycardias
Item
Biventricular Tachycardias
boolean
C0042514 (UMLS CUI 2011AA)
25569003 (SNOMED CT 2011_0131)
10047302 (MedDRA 14.1)
I47.2 (ICD-10-CM Version 2010)
E10239 (CTCAE 1105E)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Patient has been prescribed the implantation or replacement of a CRT-ICD system accordingly to the relevant currently-approved ACC/AHA15 (August 2005, Appendix § M.10) or ESC 16 (Update 2005, Appendix § M.11) guidelines or any relevant currently-approved local guidelines for the implantation or replacement of CRT-ICD.
Item
Patient has been prescribed the implantation or replacement of a CRT-ICD system accordingly to the relevant currently-approved ACC/AHA15 (August 2005, Appendix § M.10) or ESC 16 (Update 2005, Appendix § M.11) guidelines or any relevant currently-approved local guidelines for the implantation or replacement of CRT-ICD.
boolean
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C0021107 (UMLS CUI 2011AA)
71861002 (SNOMED CT 2011_0131)
MTHU035917 (LOINC Version 232)
C0559956 (UMLS CUI 2011AA)
282089006 (SNOMED CT 2011_0131)
C2936377 (UMLS CUI 2011AA)
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C0205540 (UMLS CUI 2011AA)
9571008 (SNOMED CT 2011_0131)
C0220845 (UMLS CUI 2011AA)
Patient has signed a consent form after he/she received the appropriate and mandatory information.
Item
Patient's Signature on Informed Consent Form
boolean
C2348583 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Clinical history of symptomatic or not symptomatic slow VT
Item
Clinical history of symptomatic or not symptomatic slow VT
boolean
C0021430 (UMLS CUI 2011AA)
Permanent Atrial Fibrillation (AF)
Item
permanentes Vorhofflimmern
boolean
C2586056 (UMLS CUI 2011AA)
440028005 (SNOMED CT 2011_0131)
10071668 (MedDRA 14.1)
Any contraindication to the implant or replacement of CRT-ICD
Item
Any contraindication to the implant or replacement of CRT-ICD
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0021107 (UMLS CUI 2011AA)
71861002 (SNOMED CT 2011_0131)
MTHU035917 (LOINC Version 232)
C0559956 (UMLS CUI 2011AA)
282089006 (SNOMED CT 2011_0131)
C2936377 (UMLS CUI 2011AA)
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
Pt is unable to attend the scheduled f-up visits at the implanting Centre
Item
Pt is unable to attend the scheduled f-up visits at the implanting Centre
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0086960 (UMLS CUI 2011AA)
C0589121 (UMLS CUI 2011AA)
185389009 (SNOMED CT 2011_0131)
Pt is already included in another ongoing clinical study
Item
Pt is already included in another ongoing clinical study
boolean
C2348568 (UMLS CUI 2011AA)
Pt is unable to understand the objectives of the ITAC04 study
Item
Pt is unable to understand the objectives of the ITAC04 study
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0162340 (UMLS CUI 2011AA)
66216009 (SNOMED CT 2011_0131)
C0681832 (UMLS CUI 2011AA)
Pt refuses to cooperate
Item
Pt refuses to cooperate
boolean
C0392337 (UMLS CUI 2011AA)
C1705116 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
Pt is unable or refuses to provide informed consent
Item
Pt is unable or refuses to provide informed consent
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C1705116 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
Pt is minor (less than 18-year old)
Item
Minderjähriger
boolean
C0026193 (UMLS CUI 2011AA)
410599005 (SNOMED CT 2011_0131)
Pt has life expectancy of less than 1 year
Item
Pt has life expectancy of less than 1 year
boolean
C0021430 (UMLS CUI 2011AA)
Pt is pregnant.
Item
Pt is pregnant.
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
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