ID

3807

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 11, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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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
C1576874
HL7 V3 2006_05
WRITTEN
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
C0018801
SNOMED CT 2011_0131
155374007
MedDRA 14.1
10019279
ICD-9-CM Version 2011
428
CTCAE 1105E
E10124
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
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
C0032961
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
LOINC Version 232
LP75025-4
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
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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
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
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
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
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
C0032961 (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)
LP75025-4 (LOINC Version 232)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
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