ID

5135

Description

ODM derived from http://clinicaltrials.gov/show/NCT01360008

Link

http://clinicaltrials.gov/show/NCT01360008

Keywords

Versions (2)
  1. 4/11/13 4/11/13 - Martin Dugas
  2. 4/20/14 4/20/14 - Julian Varghese
Uploaded on

April 20, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01360008 Arrhythmia

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Documented paroxysmal AF (2 episodes of PAF within the last 3 months) or Persistent AF (lasting < 1 year)
Description

Documented paroxysmal AF (2 episodes of PAF within the last 3 months) or Persistent AF (lasting < 1 year)

Data type

boolean

Alias
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0235480
SNOMED CT 2011_0131
282825002
MedDRA 14.1
10034039
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C2585653
SNOMED CT 2011_0131
440059007
MedDRA 14.1
10071667
First ablation of AF
Description

First ablation of AF

Data type

boolean

Alias
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C0547070
SNOMED CT 2011_0131
257729003
UMLS CUI 2011AA
C0004238
SNOMED CT 2011_0131
49436004
MedDRA 14.1
10003658
ICD-10-CM Version 2010
I48.0
CTCAE 1105E
E10081
Documented inefficacy of at least 1 AAD not including beta-blockers
Description

Documented inefficacy of at least 1 AAD not including beta-blockers

Data type

boolean

Alias
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1280519
SNOMED CT 2011_0131
255403003
UMLS CUI 2011AA
C0003195
SNOMED CT 2011_0131
67507000
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0001645
SNOMED CT 2011_0131
33252009
LOINC Version 232
MTHU003324
Written informed consent
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Longstanding persistent AF lasting > 1 year
Description

Longstanding persistent AF lasting > 1 year

Data type

boolean

Alias
UMLS CUI 2011AA
C0439591
SNOMED CT 2011_0131
260384008
UMLS CUI 2011AA
C2585653
SNOMED CT 2011_0131
440059007
MedDRA 14.1
10071667
ACS - Acute coronary syndrome
Description

Acute coronary syndrome (ACS)

Data type

boolean

Alias
UMLS CUI 2011AA
C0948089
SNOMED CT 2011_0131
394659003
MedDRA 14.1
10051592
CTCAE 1105E
E10066
Heart failure NYHA IV
Description

Heart failure NYHA IV

Data type

boolean

Alias
UMLS CUI 2011AA
C1319796
Thrombocytosis, thrombocytopenia
Description

Thrombocytosis, thrombocytopenia

Data type

boolean

Alias
UMLS CUI 2011AA
C0836924
SNOMED CT 2011_0131
6631009
MedDRA 14.1
10043563
UMLS CUI 2011AA
C0040034
SNOMED CT 2011_0131
302215000
MedDRA 14.1
10043554
ICD-10-CM Version 2010
D69.6
ICD-9-CM Version 2011
287.5
CTCAE 1105E
E12207
Any condition contraindicating chronic anticoagulation
Description

Any condition contraindicating chronic anticoagulation

Data type

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C1444657
SNOMED CT 2011_0131
410536001
UMLS CUI 2011AA
C1388078
Stroke or TIA within 6 months prior to ablation
Description

Stroke or TIA within 6 months prior to ablation

Data type

boolean

Alias
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
UMLS CUI 2011AA
C0007787
SNOMED CT 2011_0131
266257000
MedDRA 14.1
10044390
LOINC Version 232
MTHU020810
ICD-10-CM Version 2010
G45.9
ICD-9-CM Version 2011
435.9
CTCAE 1105E
E12834
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0547070
SNOMED CT 2011_0131
257729003
Uncontrolled hyperthyroidism
Description

Uncontrolled hyperthyroidism

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0020550
SNOMED CT 2011_0131
34486009
MedDRA 14.1
10020850
LOINC Version 232
MTHU020782
ICD-10-CM Version 2010
E05.9
ICD-9-CM Version 2011
242.9
CTCAE 1105E
E10322
Pregnancy, Gestation
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
Life expectancy < 1 year
Description

Life expectancy < 1 year

Data type

boolean

Alias
UMLS CUI 2011AA
C0023671
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Documented paroxysmal AF (2 episodes of PAF within the last 3 months) or Persistent AF (lasting < 1 year)
Item
Documented paroxysmal AF (2 episodes of PAF within the last 3 months) or Persistent AF (lasting < 1 year)
boolean
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0235480 (UMLS CUI 2011AA)
282825002 (SNOMED CT 2011_0131)
10034039 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C2585653 (UMLS CUI 2011AA)
440059007 (SNOMED CT 2011_0131)
10071667 (MedDRA 14.1)
First ablation of AF
Item
First ablation of AF
boolean
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0547070 (UMLS CUI 2011AA)
257729003 (SNOMED CT 2011_0131)
C0004238 (UMLS CUI 2011AA)
49436004 (SNOMED CT 2011_0131)
10003658 (MedDRA 14.1)
I48.0 (ICD-10-CM Version 2010)
E10081 (CTCAE 1105E)
Documented inefficacy of at least 1 AAD not including beta-blockers
Item
Documented inefficacy of at least 1 AAD not including beta-blockers
boolean
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1280519 (UMLS CUI 2011AA)
255403003 (SNOMED CT 2011_0131)
C0003195 (UMLS CUI 2011AA)
67507000 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0001645 (UMLS CUI 2011AA)
33252009 (SNOMED CT 2011_0131)
MTHU003324 (LOINC Version 232)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Longstanding persistent AF lasting > 1 year
Item
Longstanding persistent AF lasting > 1 year
boolean
C0439591 (UMLS CUI 2011AA)
260384008 (SNOMED CT 2011_0131)
C2585653 (UMLS CUI 2011AA)
440059007 (SNOMED CT 2011_0131)
10071667 (MedDRA 14.1)
Acute coronary syndrome (ACS)
Item
ACS - Acute coronary syndrome
boolean
C0948089 (UMLS CUI 2011AA)
394659003 (SNOMED CT 2011_0131)
10051592 (MedDRA 14.1)
E10066 (CTCAE 1105E)
Heart failure NYHA IV
Item
Heart failure NYHA IV
boolean
C1319796 (UMLS CUI 2011AA)
Thrombocytosis, thrombocytopenia
Item
Thrombocytosis, thrombocytopenia
boolean
C0836924 (UMLS CUI 2011AA)
6631009 (SNOMED CT 2011_0131)
10043563 (MedDRA 14.1)
C0040034 (UMLS CUI 2011AA)
302215000 (SNOMED CT 2011_0131)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
E12207 (CTCAE 1105E)
Any condition contraindicating chronic anticoagulation
Item
Any condition contraindicating chronic anticoagulation
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1444657 (UMLS CUI 2011AA)
410536001 (SNOMED CT 2011_0131)
C1388078 (UMLS CUI 2011AA)
Stroke or TIA within 6 months prior to ablation
Item
Stroke or TIA within 6 months prior to ablation
boolean
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0007787 (UMLS CUI 2011AA)
266257000 (SNOMED CT 2011_0131)
10044390 (MedDRA 14.1)
MTHU020810 (LOINC Version 232)
G45.9 (ICD-10-CM Version 2010)
435.9 (ICD-9-CM Version 2011)
E12834 (CTCAE 1105E)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0547070 (UMLS CUI 2011AA)
257729003 (SNOMED CT 2011_0131)
Uncontrolled hyperthyroidism
Item
Uncontrolled hyperthyroidism
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0020550 (UMLS CUI 2011AA)
34486009 (SNOMED CT 2011_0131)
10020850 (MedDRA 14.1)
MTHU020782 (LOINC Version 232)
E05.9 (ICD-10-CM Version 2010)
242.9 (ICD-9-CM Version 2011)
E10322 (CTCAE 1105E)
Pregnancy
Item
Pregnancy, Gestation
boolean
C0549206 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Life expectancy < 1 year
Item
Life expectancy < 1 year
boolean
C0023671 (UMLS CUI 2011AA)
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