ID

4279

Description

ODM derived from http://clinicaltrials.gov/show/NCT00729703

Link

http://clinicaltrials.gov/show/NCT00729703

Keywords

  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

December 6, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00729703 Tachycardia

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patient has been prescribed the implantation for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines 1 or ESC guidelines 35 or any relevant currently-approved local guidelines for the implantation of an ICD-system
Description

Patient has been prescribed the implantation for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines 1 or ESC guidelines 35 or any relevant currently-approved local guidelines for the implantation of an ICD-system

Data type

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
C0162589
SNOMED CT 2011_0131
72506001
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0205540
SNOMED CT 2011_0131
9571008
UMLS CUI 2011AA
C0220845
Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) <= 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.
Description

Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) <= 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.

Data type

boolean

Alias
UMLS CUI 2011AA
C0553982
SNOMED CT 2011_0131
275514001
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
UMLS CUI 2011AA
CL378222
SNOMED CT 2011_0131
77343006
MedDRA 14.1
10050062
UMLS CUI 2011AA
C0034606
SNOMED CT 2011_0131
373205008
MedDRA 14.1
10050728
ICD-9-CM Version 2011
92
UMLS CUI 2011AA
C0013516
SNOMED CT 2011_0131
40701008
MedDRA 14.1
10014116
ICD-9-CM Version 2011
88.72
UMLS CUI 2011AA
C0394239
MedDRA 14.1
10056448
An optimal (as determined by the enrolling physician) medical regimen.
Description

An optimal (as determined by the enrolling physician) medical regimen.

Data type

boolean

Alias
UMLS CUI 2011AA
C2698651
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
CL031856
UMLS CUI 2011AA
C0521095
SNOMED CT 2011_0131
436000
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
C0031831
SNOMED CT 2011_0131
309343006
LOINC Version 232
MTHU010489
HL7 V3 2006_05
PHYS
Patient's Signature on Informed Consent Form
Description

Patient has received all relevant information on the study, and has signed and dated a consent form.

Data type

boolean

Alias
UMLS CUI 2011AA
C2348583
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.
Description

Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.

Data type

boolean

Alias
UMLS CUI 2011AA
CL335836
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0199640
SNOMED CT 2011_0131
18590009
Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
Description

Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.

Data type

boolean

Alias
UMLS CUI 2011AA
CL335836
UMLS CUI 2011AA
C0021107
SNOMED CT 2011_0131
71861002
LOINC Version 232
MTHU035917
UMLS CUI 2011AA
C2936377
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0205540
SNOMED CT 2011_0131
9571008
UMLS CUI 2011AA
C0220845
Any contraindication for ICD therapy and the implant of a dual chamber ICD.
Description

Any contraindication for ICD therapy and the implant of a dual chamber ICD.

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0162589
SNOMED CT 2011_0131
72506001
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0021107
SNOMED CT 2011_0131
71861002
LOINC Version 232
MTHU035917
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0935616
UMLS CUI 2011AA
C0162589
SNOMED CT 2011_0131
72506001
ICD replacement
Description

ICD replacement

Data type

boolean

Alias
UMLS CUI 2011AA
C0162589
SNOMED CT 2011_0131
72506001
UMLS CUI 2011AA
C0559956
SNOMED CT 2011_0131
282089006
Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.
Description

Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0085611
SNOMED CT 2011_0131
17366009
MedDRA 14.1
10003656
UMLS CUI 2011AA
C0013778
SNOMED CT 2011_0131
250980009
MedDRA 14.1
10007661
UMLS CUI 2011AA
C0004238
SNOMED CT 2011_0131
49436004
MedDRA 14.1
10003658
ICD-10-CM Version 2010
I48.0
CTCAE 1105E
E10081
UMLS CUI 2011AA
C1444637
SNOMED CT 2011_0131
410513005
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
A PR interval > 250 ms or AR interval > 300 ms measured at implant.
Description

A PR interval > 250 ms or AR interval > 300 ms measured at implant.

Data type

boolean

Alias
UMLS CUI 2011AA
C0429087
SNOMED CT 2011_0131
365411005
MedDRA 14.1
10050656
UMLS CUI 2011AA
C1706281
SNOMED CT 2011_0131
422097006
UMLS CUI 2011AA
C0439117
SNOMED CT 2011_0131
257974004
UMLS CUI 2011AA
C1272706
SNOMED CT 2011_0131
385673002
UMLS CUI 2011AA
C0444706
SNOMED CT 2011_0131
258104002
UMLS CUI 2011AA
C0021107
SNOMED CT 2011_0131
71861002
LOINC Version 232
MTHU035917
Idiopathic hypertrophic subaortic stenosis
Description

Hypertrophic obstructive cardiomyopathy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0700053
SNOMED CT 2011_0131
360465008
MedDRA 14.1
10021230
ICD-10-CM Version 2010
I42.1
Acute myocarditis
Description

Acute myocarditis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0155686
SNOMED CT 2011_0131
46701001
MedDRA 14.1
10000932
ICD-10-CM Version 2010
I40.9
ICD-9-CM Version 2011
422.90
Unstable coronary symptoms or myocardial infarction within the last month.
Description

Unstable coronary symptoms or myocardial infarction within the last month.

Data type

boolean

Alias
UMLS CUI 2011AA
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0018787
SNOMED CT 2011_0131
80891009
LOINC Version 232
MTHU001067
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.
Description

Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.

Data type

boolean

Alias
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0027056
SNOMED CT 2011_0131
81266008
UMLS CUI 2011AA
C0190211
SNOMED CT 2011_0131
41339005
MedDRA 14.1
10050329
Recently performed (in the last month) or planned cardiac surgery
Description

Recently performed (in the last month) or planned cardiac surgery

Data type

boolean

Alias
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0018821
SNOMED CT 2011_0131
64915003
MedDRA 14.1
10061026
Already included in another clinical study.
Description

Already included in another clinical study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008972
Life expectancy less than 24 months.
Description

Life expectancy less than 24 months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Inability to understand the purpose of the study or refusal to cooperate.
Description

Inability to understand the purpose of the study or refusal to cooperate.

Data type

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0162340
SNOMED CT 2011_0131
66216009
UMLS CUI 2011AA
C0681832
UMLS CUI 2011AA
C2733540
SNOMED CT 2011_0131
443390004
UMLS CUI 2011AA
C0392337
Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.
Description

Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.

Data type

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C2733540
SNOMED CT 2011_0131
443390004
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
UMLS CUI 2011AA
C0600593
UMLS CUI 2011AA
C1524004
Unavailability for scheduled follow-up at the implanting or cooperating center.
Description

Unavailability for scheduled follow-up at the implanting or cooperating center.

Data type

boolean

Alias
UMLS CUI 2011AA
C0686905
SNOMED CT 2011_0131
397854000
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C1522577
Age < 18 years
Description

Age < 18 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Pregnancy, Gestation
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patient has been prescribed the implantation for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines 1 or ESC guidelines 35 or any relevant currently-approved local guidelines for the implantation of an ICD-system
Item
Patient has been prescribed the implantation for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines 1 or ESC guidelines 35 or any relevant currently-approved local guidelines for the implantation of an ICD-system
boolean
C0033080 (UMLS CUI 2011AA)
16076005 (SNOMED CT 2011_0131)
C0021107 (UMLS CUI 2011AA)
71861002 (SNOMED CT 2011_0131)
MTHU035917 (LOINC Version 232)
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)
Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) <= 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.
Item
Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) <= 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.
boolean
C0553982 (UMLS CUI 2011AA)
275514001 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
CL378222 (UMLS CUI 2011AA)
77343006 (SNOMED CT 2011_0131)
10050062 (MedDRA 14.1)
C0034606 (UMLS CUI 2011AA)
373205008 (SNOMED CT 2011_0131)
10050728 (MedDRA 14.1)
92 (ICD-9-CM Version 2011)
C0013516 (UMLS CUI 2011AA)
40701008 (SNOMED CT 2011_0131)
10014116 (MedDRA 14.1)
88.72 (ICD-9-CM Version 2011)
C0394239 (UMLS CUI 2011AA)
10056448 (MedDRA 14.1)
An optimal (as determined by the enrolling physician) medical regimen.
Item
An optimal (as determined by the enrolling physician) medical regimen.
boolean
C2698651 (UMLS CUI 2011AA)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
CL031856 (UMLS CUI 2011AA)
C0521095 (UMLS CUI 2011AA)
436000 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
Patient has received all relevant information on the study, and has signed and dated a consent form.
Item
Patient's Signature on Informed Consent Form
boolean
C2348583 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.
Item
Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.
boolean
CL335836 (UMLS CUI 2011AA)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C2828392 (UMLS CUI 2011AA)
C0199640 (UMLS CUI 2011AA)
18590009 (SNOMED CT 2011_0131)
Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
Item
Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
boolean
CL335836 (UMLS CUI 2011AA)
C0021107 (UMLS CUI 2011AA)
71861002 (SNOMED CT 2011_0131)
MTHU035917 (LOINC Version 232)
C2936377 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0205540 (UMLS CUI 2011AA)
9571008 (SNOMED CT 2011_0131)
C0220845 (UMLS CUI 2011AA)
Any contraindication for ICD therapy and the implant of a dual chamber ICD.
Item
Any contraindication for ICD therapy and the implant of a dual chamber ICD.
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0021107 (UMLS CUI 2011AA)
71861002 (SNOMED CT 2011_0131)
MTHU035917 (LOINC Version 232)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0935616 (UMLS CUI 2011AA)
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
ICD replacement
Item
ICD replacement
boolean
C0162589 (UMLS CUI 2011AA)
72506001 (SNOMED CT 2011_0131)
C0559956 (UMLS CUI 2011AA)
282089006 (SNOMED CT 2011_0131)
Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.
Item
Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0085611 (UMLS CUI 2011AA)
17366009 (SNOMED CT 2011_0131)
10003656 (MedDRA 14.1)
C0013778 (UMLS CUI 2011AA)
250980009 (SNOMED CT 2011_0131)
10007661 (MedDRA 14.1)
C0004238 (UMLS CUI 2011AA)
49436004 (SNOMED CT 2011_0131)
10003658 (MedDRA 14.1)
I48.0 (ICD-10-CM Version 2010)
E10081 (CTCAE 1105E)
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
A PR interval > 250 ms or AR interval > 300 ms measured at implant.
Item
A PR interval > 250 ms or AR interval > 300 ms measured at implant.
boolean
C0429087 (UMLS CUI 2011AA)
365411005 (SNOMED CT 2011_0131)
10050656 (MedDRA 14.1)
C1706281 (UMLS CUI 2011AA)
422097006 (SNOMED CT 2011_0131)
C0439117 (UMLS CUI 2011AA)
257974004 (SNOMED CT 2011_0131)
C1272706 (UMLS CUI 2011AA)
385673002 (SNOMED CT 2011_0131)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C0021107 (UMLS CUI 2011AA)
71861002 (SNOMED CT 2011_0131)
MTHU035917 (LOINC Version 232)
Hypertrophic obstructive cardiomyopathy.
Item
Idiopathic hypertrophic subaortic stenosis
boolean
C0700053 (UMLS CUI 2011AA)
360465008 (SNOMED CT 2011_0131)
10021230 (MedDRA 14.1)
I42.1 (ICD-10-CM Version 2010)
Acute myocarditis.
Item
Acute myocarditis
boolean
C0155686 (UMLS CUI 2011AA)
46701001 (SNOMED CT 2011_0131)
10000932 (MedDRA 14.1)
I40.9 (ICD-10-CM Version 2010)
422.90 (ICD-9-CM Version 2011)
Unstable coronary symptoms or myocardial infarction within the last month.
Item
Unstable coronary symptoms or myocardial infarction within the last month.
boolean
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0018787 (UMLS CUI 2011AA)
80891009 (SNOMED CT 2011_0131)
MTHU001067 (LOINC Version 232)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.
Item
Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.
boolean
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0027056 (UMLS CUI 2011AA)
81266008 (SNOMED CT 2011_0131)
C0190211 (UMLS CUI 2011AA)
41339005 (SNOMED CT 2011_0131)
10050329 (MedDRA 14.1)
Recently performed (in the last month) or planned cardiac surgery
Item
Recently performed (in the last month) or planned cardiac surgery
boolean
C1517741 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0018821 (UMLS CUI 2011AA)
64915003 (SNOMED CT 2011_0131)
10061026 (MedDRA 14.1)
Already included in another clinical study.
Item
Already included in another clinical study.
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008972 (UMLS CUI 2011AA)
Life expectancy less than 24 months.
Item
Life expectancy less than 24 months.
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Inability to understand the purpose of the study or refusal to cooperate.
Item
Inability to understand the purpose of the study or refusal to cooperate.
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0162340 (UMLS CUI 2011AA)
66216009 (SNOMED CT 2011_0131)
C0681832 (UMLS CUI 2011AA)
C2733540 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
C0392337 (UMLS CUI 2011AA)
Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.
Item
Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C2733540 (UMLS CUI 2011AA)
443390004 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
C0600593 (UMLS CUI 2011AA)
C1524004 (UMLS CUI 2011AA)
Unavailability for scheduled follow-up at the implanting or cooperating center.
Item
Unavailability for scheduled follow-up at the implanting or cooperating center.
boolean
C0686905 (UMLS CUI 2011AA)
397854000 (SNOMED CT 2011_0131)
C0086960 (UMLS CUI 2011AA)
C1522577 (UMLS CUI 2011AA)
Age < 18 years
Item
Age < 18 years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Pregnancy
Item
Pregnancy, Gestation
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)

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