ID

4469

Description

ODM derived from http://clinicaltrials.gov/show/NCT00408473

Link

http://clinicaltrials.gov/show/NCT00408473

Keywords

Versions (1)
  1. 12/9/13 12/9/13 - Martin Dugas
Uploaded on

December 9, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00408473 Atrial Fibrillation

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 65 Years
Description

age 18 Years to 65 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
History of first symptomatic & documented episode of AF
Description

History of first symptomatic & documented episode of AF

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0332189
SNOMED CT 2011_0131
272128006
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
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
LVEF > 40% and not on AAD and in sinus rhythm at time of recruitment
Description

LVEF > 40% and not on AAD and in sinus rhythm at time of recruitment

Data type

boolean

Alias
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0003195
SNOMED CT 2011_0131
67507000
UMLS CUI 2011AA
C0232201
SNOMED CT 2011_0131
251150006
MedDRA 14.1
10048815
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C2949735
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
History of more than 1 symptomatic documented AF episode, persistent or permanent AF.
Description

History of more than 1 symptomatic documented AF episode, persistent or permanent AF.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0231220
SNOMED CT 2011_0131
264931009
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
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
C0332189
SNOMED CT 2011_0131
272128006
UMLS CUI 2011AA
C2585653
SNOMED CT 2011_0131
440059007
MedDRA 14.1
10071667
UMLS CUI 2011AA
C2586056
SNOMED CT 2011_0131
440028005
MedDRA 14.1
10071668
History of ablation for previous AF
Description

History of ablation for previous AF

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0547070
SNOMED CT 2011_0131
257729003
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0004238
SNOMED CT 2011_0131
49436004
MedDRA 14.1
10003658
ICD-10-CM Version 2010
I48.0
CTCAE 1105E
E10081
Reversible cause for AF (e.g.thyroid, alcohol, pulmonary embolism, surgery
Description

Reversible cause for AF (e.g.thyroid, alcohol, pulmonary embolism, surgery

Data type

boolean

Alias
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
C0205343
SNOMED CT 2011_0131
35174006
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
C0040128
SNOMED CT 2011_0131
14304000
MedDRA 14.1
10043709
ICD-10-CM Version 2010
E00-E07
ICD-9-CM Version 2011
240-246.99
UMLS CUI 2011AA
C0085762
SNOMED CT 2011_0131
15167005
MedDRA 14.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
UMLS CUI 2011AA
C0034065
SNOMED CT 2011_0131
59282003
MedDRA 14.1
10037377
ICD-10-CM Version 2010
I26
ICD-9-CM Version 2011
415.1
UMLS CUI 2011AA
C0038895
Severe symptoms during AF episode (e.g.syncope, chest pain)
Description

Severe symptoms during AF episode (e.g.syncope, chest pain)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
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
C0332189
SNOMED CT 2011_0131
272128006
UMLS CUI 2011AA
C0039070
SNOMED CT 2011_0131
272030005
MedDRA 14.1
10042772
LOINC Version 232
MTHU020851
ICD-10-CM Version 2010
R55
ICD-9-CM Version 2011
780.2
CTCAE 1105E
E12832
UMLS CUI 2011AA
C0008031
SNOMED CT 2011_0131
29857009
MedDRA 14.1
10008479
LOINC Version 232
MTHU035552
ICD-10-CM Version 2010
R07.9
ICD-9-CM Version 2011
786.5
All types of treated arrhythmias other than AF
Description

All types of treated arrhythmias other than AF

Data type

boolean

Alias
UMLS CUI 2011AA
C0444868
SNOMED CT 2011_0131
261675009
UMLS CUI 2011AA
C0332307
SNOMED CT 2011_0131
410657003
LOINC Version 232
MTHU013727
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0004238
SNOMED CT 2011_0131
49436004
MedDRA 14.1
10003658
ICD-10-CM Version 2010
I48.0
CTCAE 1105E
E10081
History of myocardial infarction (MI), coronary artery disease (CAD), heart failure (I, II, III and IV of New York Heart Association -NYHA- classification) or valvular diseases
Description

History of myocardial infarction (MI), coronary artery disease (CAD), heart failure (I, II, III and IV of New York Heart Association -NYHA- classification) or valvular diseases

Data type

boolean

Alias
UMLS CUI 2011AA
C1275835
SNOMED CT 2011_0131
399211009
UMLS CUI 2011AA
C1881055
UMLS CUI 2011AA
C0455531
SNOMED CT 2011_0131
161505003
UMLS CUI 2011AA
C1319793
SNOMED CT 2011_0131
420300004
MedDRA 14.1
10064079
UMLS CUI 2011AA
C1319794
SNOMED CT 2011_0131
421704003
MedDRA 14.1
10064080
UMLS CUI 2011AA
C1319795
SNOMED CT 2011_0131
420913000
MedDRA 14.1
10064081
UMLS CUI 2011AA
C1319796
SNOMED CT 2011_0131
422293003
MedDRA 14.1
10064082
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0026265
SNOMED CT 2011_0131
11851006
MedDRA 14.1
10061532
ICD-9-CM Version 2011
424.0
CTCAE 1105E
E10134
LVEF - Left ventricular ejection fraction
Description

Left ventricular ejection fraction (LVEF) <= 40%

Data type

boolean

Alias
UMLS CUI 2011AA
C0428772
SNOMED CT 2011_0131
250908004
MedDRA 14.1
10069170
Bradycardia < 40 beats/min and all ECG abnormalities: PR> 240ms or QRS> 120 ms or QTc> 440 ms
Description

Bradycardia < 40 beats/min and all ECG abnormalities: PR> 240ms or QRS> 120 ms or QTc> 440 ms

Data type

boolean

Alias
UMLS CUI 2011AA
C0428977
SNOMED CT 2011_0131
48867003
MedDRA 14.1
10006093
ICD-10-CM Version 2010
R00.1
UMLS CUI 2011AA
C0425583
SNOMED CT 2011_0131
248646004
LOINC Version 232
MTHU002606
UMLS CUI 2011AA
C1282918
SNOMED CT 2011_0131
356624006
UMLS CUI 2011AA
C0522055
SNOMED CT 2011_0131
102594003
MedDRA 14.1
10014363
UMLS CUI 2011AA
C0429087
SNOMED CT 2011_0131
365411005
MedDRA 14.1
10050656
UMLS CUI 2011AA
C0520880
SNOMED CT 2011_0131
39632005
UMLS CUI 2011AA
C0489625
LOINC Version 232
MTHU024527
Brugada Syndrome (disorder)
Description

Brugada syndrome

Data type

boolean

Alias
UMLS CUI 2011AA
C1142166
SNOMED CT 2011_0131
418818005
MedDRA 14.1
10059027
Conduction disturbances: complete bundle branch block (LBBB) or (RBBB), bifascicular block
Description

Conduction disturbances: complete bundle branch block (LBBB) or (RBBB), bifascicular block

Data type

boolean

Alias
UMLS CUI 2011AA
C0264886
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10010276
ICD-10-CM Version 2010
I45.9
ICD-9-CM Version 2011
426.9
CTCAE 1105E
E10114
UMLS CUI 2011AA
C0205197
SNOMED CT 2011_0131
255594003
UMLS CUI 2011AA
C0006384
SNOMED CT 2011_0131
6374002
MedDRA 14.1
10006578
ICD-10-CM Version 2010
I45.4
ICD-9-CM Version 2011
426.50
UMLS CUI 2011AA
C0023211
SNOMED CT 2011_0131
63467002
MedDRA 14.1
10006580
ICD-10-CM Version 2010
I44.7
UMLS CUI 2011AA
C0085615
SNOMED CT 2011_0131
59118001
MedDRA 14.1
10006582
ICD-10-CM Version 2010
I45.10
ICD-9-CM Version 2011
426.4
UMLS CUI 2011AA
C0264914
SNOMED CT 2011_0131
74021003
MedDRA 14.1
10057393
ICD-10-CM Version 2010
I45.2
2nd or 3rd degree atrioventricular (AV) block
Description

2nd or 3rd degree atrioventricular (AV) block

Data type

boolean

Alias
UMLS CUI 2011AA
C0205436
SNOMED CT 2011_0131
81170007
UMLS CUI 2011AA
C0205437
SNOMED CT 2011_0131
70905002
UMLS CUI 2011AA
C0449286
SNOMED CT 2011_0131
246173007
UMLS CUI 2011AA
C0004245
SNOMED CT 2011_0131
233917008
MedDRA 14.1
10003671
ICD-10-CM Version 2010
I44.30
ICD-9-CM Version 2011
426.10
Coronary sinus rhythm disorder
Description

Sinus node dysfunction

Data type

boolean

Alias
UMLS CUI 2011AA
C0428908
SNOMED CT 2011_0131
60423000
MedDRA 14.1
10040737
ICD-10-CM Version 2010
I49.8
ICD-9-CM Version 2011
427.81
Severe hypertension with:Systolic blood pressure >= 180 mmHg, and / or Diastolic blood pressure >= 100 mmHg
Description

Severe hypertension with:Systolic blood pressure >= 180 mmHg, and / or Diastolic blood pressure >= 100 mmHg

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0020538
SNOMED CT 2011_0131
38341003
MedDRA 14.1
10020772
LOINC Version 232
MTHU020789
ICD-10-CM Version 2010
I10
ICD-9-CM Version 2011
997.91
CTCAE 1105E
E13785
UMLS CUI 2011AA
C0871470
SNOMED CT 2011_0131
271649006
UMLS CUI 2011AA
C0428883
SNOMED CT 2011_0131
271650006
Left ventricular hypertrophy (LVH) with septal thickness > 14 mm on Echocardiogram
Description

Left ventricular hypertrophy (LVH) with septal thickness > 14 mm on Echocardiogram

Data type

boolean

Alias
UMLS CUI 2011AA
C0149721
SNOMED CT 2011_0131
55827005
MedDRA 14.1
10049773
UMLS CUI 2011AA
C0442004
SNOMED CT 2011_0131
255584008
UMLS CUI 2011AA
C1280412
SNOMED CT 2011_0131
246703001
LOINC Version 232
MTHU002984
UMLS CUI 2011AA
C2243117
(Artificial) Cardiac pacemaker
Description

Implanted pacemaker

Data type

boolean

Alias
UMLS CUI 2011AA
C0030163
SNOMED CT 2011_0131
14106009
LOINC Version 232
MTHU024521
Heart surgery within the last 6 months, or non-stable postoperative condition
Description

Heart surgery within the last 6 months, or non-stable postoperative condition

Data type

boolean

Alias
UMLS CUI 2011AA
C0524727
SNOMED CT 2011_0131
408466002
UMLS CUI 2011AA
C1517741
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
C0443343
SNOMED CT 2011_0131
263922001
UMLS CUI 2011AA
C0231287
SNOMED CT 2011_0131
19585003
Renal failure: serum creatinine >= 150 µmol/l or creatinine clearance <= 50 ml/min (Cockroft and Gault formula
Description

Renal failure: serum creatinine >= 150 µmol/l or creatinine clearance <= 50 ml/min (Cockroft and Gault formula

Data type

boolean

Alias
UMLS CUI 2011AA
C1565489
MedDRA 14.1
10038474
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
UMLS CUI 2011AA
C2711451
SNOMED CT 2011_0131
442407001
Uncorrected electrolytic abnormalities
Description

Uncorrected electrolytic abnormalities

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205202
SNOMED CT 2011_0131
33714007
UMLS CUI 2011AA
CL354536
Have used recently in the last 3 months prior to the inclusion any of the following treatments: Oral amiodarone, Treatments that lengthen QT interval (e.g.Sultopride, Drugs causing torsades de pointe (e.g.mizolastine, pentamidine, sparfloxacin, moxifloxacin, Bupropion
Description

Have used recently in the last 3 months prior to the inclusion any of the following treatments: Oral amiodarone, Treatments that lengthen QT interval (e.g.Sultopride, Drugs causing torsades de pointe (e.g.mizolastine, pentamidine, sparfloxacin, moxifloxacin, Bupropion

Data type

boolean

Alias
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
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
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0002598
SNOMED CT 2011_0131
372821002
LOINC Version 232
MTHU004841
UMLS CUI 2011AA
C0151878
SNOMED CT 2011_0131
111975006
MedDRA 14.1
10014387
CTCAE 1105E
E12146
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0075630
UMLS CUI 2011AA
C0040479
SNOMED CT 2011_0131
31722008
MedDRA 14.1
10044066
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
C1254351
UMLS CUI 2011AA
C0171302
SNOMED CT 2011_0131
395798005
UMLS CUI 2011AA
C0030863
SNOMED CT 2011_0131
372699006
UMLS CUI 2011AA
C0052585
SNOMED CT 2011_0131
387554008
LOINC Version 232
MTHU009179
UMLS CUI 2011AA
C0536495
SNOMED CT 2011_0131
412439003
LOINC Version 232
MTHU014635
UMLS CUI 2011AA
C0085208
SNOMED CT 2011_0131
387564004
LOINC Version 232
MTHU022987
Anti-hypertensive drugs other than permitted in the study: ACE-I, ARB (sartans) and DHP from Calcium channel blockers (CCB
Description

Anti-hypertensive drugs other than permitted in the study: ACE-I, ARB (sartans) and DHP from Calcium channel blockers (CCB

Data type

boolean

Alias
UMLS CUI 2011AA
C0003364
SNOMED CT 2011_0131
372586001
UMLS CUI 2011AA
C1554075
HL7 V3 2006_05
NP
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0003015
SNOMED CT 2011_0131
372733002
UMLS CUI 2011AA
C0521942
SNOMED CT 2011_0131
372913009
UMLS CUI 2011AA
C1563745
UMLS CUI 2011AA
C0220821
UMLS CUI 2011AA
C0006684
SNOMED CT 2011_0131
373304005
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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
CL425202 (UMLS CUI 2011AA)
age 18 Years to 65 Years
Item
age 18 Years to 65 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
History of first symptomatic & documented episode of AF
Item
History of first symptomatic & documented episode of AF
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0332189 (UMLS CUI 2011AA)
272128006 (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)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
LVEF > 40% and not on AAD and in sinus rhythm at time of recruitment
Item
LVEF > 40% and not on AAD and in sinus rhythm at time of recruitment
boolean
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
C1518422 (UMLS CUI 2011AA)
C0003195 (UMLS CUI 2011AA)
67507000 (SNOMED CT 2011_0131)
C0232201 (UMLS CUI 2011AA)
251150006 (SNOMED CT 2011_0131)
10048815 (MedDRA 14.1)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C2949735 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
History of more than 1 symptomatic documented AF episode, persistent or permanent AF.
Item
History of more than 1 symptomatic documented AF episode, persistent or permanent AF.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C1301725 (UMLS CUI 2011AA)
397934002 (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)
C0332189 (UMLS CUI 2011AA)
272128006 (SNOMED CT 2011_0131)
C2585653 (UMLS CUI 2011AA)
440059007 (SNOMED CT 2011_0131)
10071667 (MedDRA 14.1)
C2586056 (UMLS CUI 2011AA)
440028005 (SNOMED CT 2011_0131)
10071668 (MedDRA 14.1)
History of ablation for previous AF
Item
History of ablation for previous AF
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0547070 (UMLS CUI 2011AA)
257729003 (SNOMED CT 2011_0131)
C0205156 (UMLS CUI 2011AA)
9130008 (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)
Reversible cause for AF (e.g.thyroid, alcohol, pulmonary embolism, surgery
Item
Reversible cause for AF (e.g.thyroid, alcohol, pulmonary embolism, surgery
boolean
C0004238 (UMLS CUI 2011AA)
49436004 (SNOMED CT 2011_0131)
10003658 (MedDRA 14.1)
I48.0 (ICD-10-CM Version 2010)
E10081 (CTCAE 1105E)
C0205343 (UMLS CUI 2011AA)
35174006 (SNOMED CT 2011_0131)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C0040128 (UMLS CUI 2011AA)
14304000 (SNOMED CT 2011_0131)
10043709 (MedDRA 14.1)
E00-E07 (ICD-10-CM Version 2010)
240-246.99 (ICD-9-CM Version 2011)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
C0034065 (UMLS CUI 2011AA)
59282003 (SNOMED CT 2011_0131)
10037377 (MedDRA 14.1)
I26 (ICD-10-CM Version 2010)
415.1 (ICD-9-CM Version 2011)
C0038895 (UMLS CUI 2011AA)
Severe symptoms during AF episode (e.g.syncope, chest pain)
Item
Severe symptoms during AF episode (e.g.syncope, chest pain)
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0347984 (UMLS CUI 2011AA)
371881003 (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)
C0332189 (UMLS CUI 2011AA)
272128006 (SNOMED CT 2011_0131)
C0039070 (UMLS CUI 2011AA)
272030005 (SNOMED CT 2011_0131)
10042772 (MedDRA 14.1)
MTHU020851 (LOINC Version 232)
R55 (ICD-10-CM Version 2010)
780.2 (ICD-9-CM Version 2011)
E12832 (CTCAE 1105E)
C0008031 (UMLS CUI 2011AA)
29857009 (SNOMED CT 2011_0131)
10008479 (MedDRA 14.1)
MTHU035552 (LOINC Version 232)
R07.9 (ICD-10-CM Version 2010)
786.5 (ICD-9-CM Version 2011)
All types of treated arrhythmias other than AF
Item
All types of treated arrhythmias other than AF
boolean
C0444868 (UMLS CUI 2011AA)
261675009 (SNOMED CT 2011_0131)
C0332307 (UMLS CUI 2011AA)
410657003 (SNOMED CT 2011_0131)
MTHU013727 (LOINC Version 232)
CL415147 (UMLS CUI 2011AA)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
CL411789 (UMLS CUI 2011AA)
C0004238 (UMLS CUI 2011AA)
49436004 (SNOMED CT 2011_0131)
10003658 (MedDRA 14.1)
I48.0 (ICD-10-CM Version 2010)
E10081 (CTCAE 1105E)
History of myocardial infarction (MI), coronary artery disease (CAD), heart failure (I, II, III and IV of New York Heart Association -NYHA- classification) or valvular diseases
Item
History of myocardial infarction (MI), coronary artery disease (CAD), heart failure (I, II, III and IV of New York Heart Association -NYHA- classification) or valvular diseases
boolean
C1275835 (UMLS CUI 2011AA)
399211009 (SNOMED CT 2011_0131)
C1881055 (UMLS CUI 2011AA)
C0455531 (UMLS CUI 2011AA)
161505003 (SNOMED CT 2011_0131)
C1319793 (UMLS CUI 2011AA)
420300004 (SNOMED CT 2011_0131)
10064079 (MedDRA 14.1)
C1319794 (UMLS CUI 2011AA)
421704003 (SNOMED CT 2011_0131)
10064080 (MedDRA 14.1)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0026265 (UMLS CUI 2011AA)
11851006 (SNOMED CT 2011_0131)
10061532 (MedDRA 14.1)
424.0 (ICD-9-CM Version 2011)
E10134 (CTCAE 1105E)
Left ventricular ejection fraction (LVEF) <= 40%
Item
LVEF - Left ventricular ejection fraction
boolean
C0428772 (UMLS CUI 2011AA)
250908004 (SNOMED CT 2011_0131)
10069170 (MedDRA 14.1)
Bradycardia < 40 beats/min and all ECG abnormalities: PR> 240ms or QRS> 120 ms or QTc> 440 ms
Item
Bradycardia < 40 beats/min and all ECG abnormalities: PR> 240ms or QRS> 120 ms or QTc> 440 ms
boolean
C0428977 (UMLS CUI 2011AA)
48867003 (SNOMED CT 2011_0131)
10006093 (MedDRA 14.1)
R00.1 (ICD-10-CM Version 2010)
C0425583 (UMLS CUI 2011AA)
248646004 (SNOMED CT 2011_0131)
MTHU002606 (LOINC Version 232)
C1282918 (UMLS CUI 2011AA)
356624006 (SNOMED CT 2011_0131)
C0522055 (UMLS CUI 2011AA)
102594003 (SNOMED CT 2011_0131)
10014363 (MedDRA 14.1)
C0429087 (UMLS CUI 2011AA)
365411005 (SNOMED CT 2011_0131)
10050656 (MedDRA 14.1)
C0520880 (UMLS CUI 2011AA)
39632005 (SNOMED CT 2011_0131)
C0489625 (UMLS CUI 2011AA)
MTHU024527 (LOINC Version 232)
Brugada syndrome
Item
Brugada Syndrome (disorder)
boolean
C1142166 (UMLS CUI 2011AA)
418818005 (SNOMED CT 2011_0131)
10059027 (MedDRA 14.1)
Conduction disturbances: complete bundle branch block (LBBB) or (RBBB), bifascicular block
Item
Conduction disturbances: complete bundle branch block (LBBB) or (RBBB), bifascicular block
boolean
C0264886 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10010276 (MedDRA 14.1)
I45.9 (ICD-10-CM Version 2010)
426.9 (ICD-9-CM Version 2011)
E10114 (CTCAE 1105E)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0006384 (UMLS CUI 2011AA)
6374002 (SNOMED CT 2011_0131)
10006578 (MedDRA 14.1)
I45.4 (ICD-10-CM Version 2010)
426.50 (ICD-9-CM Version 2011)
C0023211 (UMLS CUI 2011AA)
63467002 (SNOMED CT 2011_0131)
10006580 (MedDRA 14.1)
I44.7 (ICD-10-CM Version 2010)
C0085615 (UMLS CUI 2011AA)
59118001 (SNOMED CT 2011_0131)
10006582 (MedDRA 14.1)
I45.10 (ICD-10-CM Version 2010)
426.4 (ICD-9-CM Version 2011)
C0264914 (UMLS CUI 2011AA)
74021003 (SNOMED CT 2011_0131)
10057393 (MedDRA 14.1)
I45.2 (ICD-10-CM Version 2010)
2nd or 3rd degree atrioventricular (AV) block
Item
2nd or 3rd degree atrioventricular (AV) block
boolean
C0205436 (UMLS CUI 2011AA)
81170007 (SNOMED CT 2011_0131)
C0205437 (UMLS CUI 2011AA)
70905002 (SNOMED CT 2011_0131)
C0449286 (UMLS CUI 2011AA)
246173007 (SNOMED CT 2011_0131)
C0004245 (UMLS CUI 2011AA)
233917008 (SNOMED CT 2011_0131)
10003671 (MedDRA 14.1)
I44.30 (ICD-10-CM Version 2010)
426.10 (ICD-9-CM Version 2011)
Sinus node dysfunction
Item
Coronary sinus rhythm disorder
boolean
C0428908 (UMLS CUI 2011AA)
60423000 (SNOMED CT 2011_0131)
10040737 (MedDRA 14.1)
I49.8 (ICD-10-CM Version 2010)
427.81 (ICD-9-CM Version 2011)
Severe hypertension with:Systolic blood pressure >= 180 mmHg, and / or Diastolic blood pressure >= 100 mmHg
Item
Severe hypertension with:Systolic blood pressure >= 180 mmHg, and / or Diastolic blood pressure >= 100 mmHg
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0020538 (UMLS CUI 2011AA)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)
C0871470 (UMLS CUI 2011AA)
271649006 (SNOMED CT 2011_0131)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
Left ventricular hypertrophy (LVH) with septal thickness > 14 mm on Echocardiogram
Item
Left ventricular hypertrophy (LVH) with septal thickness > 14 mm on Echocardiogram
boolean
C0149721 (UMLS CUI 2011AA)
55827005 (SNOMED CT 2011_0131)
10049773 (MedDRA 14.1)
C0442004 (UMLS CUI 2011AA)
255584008 (SNOMED CT 2011_0131)
C1280412 (UMLS CUI 2011AA)
246703001 (SNOMED CT 2011_0131)
MTHU002984 (LOINC Version 232)
C2243117 (UMLS CUI 2011AA)
Implanted pacemaker
Item
(Artificial) Cardiac pacemaker
boolean
C0030163 (UMLS CUI 2011AA)
14106009 (SNOMED CT 2011_0131)
MTHU024521 (LOINC Version 232)
Heart surgery within the last 6 months, or non-stable postoperative condition
Item
Heart surgery within the last 6 months, or non-stable postoperative condition
boolean
C0524727 (UMLS CUI 2011AA)
408466002 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0443343 (UMLS CUI 2011AA)
263922001 (SNOMED CT 2011_0131)
C0231287 (UMLS CUI 2011AA)
19585003 (SNOMED CT 2011_0131)
Renal failure: serum creatinine >= 150 µmol/l or creatinine clearance <= 50 ml/min (Cockroft and Gault formula
Item
Renal failure: serum creatinine >= 150 µmol/l or creatinine clearance <= 50 ml/min (Cockroft and Gault formula
boolean
C1565489 (UMLS CUI 2011AA)
10038474 (MedDRA 14.1)
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
C2711451 (UMLS CUI 2011AA)
442407001 (SNOMED CT 2011_0131)
Uncorrected electrolytic abnormalities
Item
Uncorrected electrolytic abnormalities
boolean
C1518422 (UMLS CUI 2011AA)
C0205202 (UMLS CUI 2011AA)
33714007 (SNOMED CT 2011_0131)
CL354536 (UMLS CUI 2011AA)
Have used recently in the last 3 months prior to the inclusion any of the following treatments: Oral amiodarone, Treatments that lengthen QT interval (e.g.Sultopride, Drugs causing torsades de pointe (e.g.mizolastine, pentamidine, sparfloxacin, moxifloxacin, Bupropion
Item
Have used recently in the last 3 months prior to the inclusion any of the following treatments: Oral amiodarone, Treatments that lengthen QT interval (e.g.Sultopride, Drugs causing torsades de pointe (e.g.mizolastine, pentamidine, sparfloxacin, moxifloxacin, Bupropion
boolean
C1517741 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (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)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
CL407060 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0002598 (UMLS CUI 2011AA)
372821002 (SNOMED CT 2011_0131)
MTHU004841 (LOINC Version 232)
C0151878 (UMLS CUI 2011AA)
111975006 (SNOMED CT 2011_0131)
10014387 (MedDRA 14.1)
E12146 (CTCAE 1105E)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0075630 (UMLS CUI 2011AA)
C0040479 (UMLS CUI 2011AA)
31722008 (SNOMED CT 2011_0131)
10044066 (MedDRA 14.1)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C1254351 (UMLS CUI 2011AA)
C0171302 (UMLS CUI 2011AA)
395798005 (SNOMED CT 2011_0131)
C0030863 (UMLS CUI 2011AA)
372699006 (SNOMED CT 2011_0131)
C0052585 (UMLS CUI 2011AA)
387554008 (SNOMED CT 2011_0131)
MTHU009179 (LOINC Version 232)
C0536495 (UMLS CUI 2011AA)
412439003 (SNOMED CT 2011_0131)
MTHU014635 (LOINC Version 232)
C0085208 (UMLS CUI 2011AA)
387564004 (SNOMED CT 2011_0131)
MTHU022987 (LOINC Version 232)
Anti-hypertensive drugs other than permitted in the study: ACE-I, ARB (sartans) and DHP from Calcium channel blockers (CCB
Item
Anti-hypertensive drugs other than permitted in the study: ACE-I, ARB (sartans) and DHP from Calcium channel blockers (CCB
boolean
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
C1554075 (UMLS CUI 2011AA)
NP (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0003015 (UMLS CUI 2011AA)
372733002 (SNOMED CT 2011_0131)
C0521942 (UMLS CUI 2011AA)
372913009 (SNOMED CT 2011_0131)
C1563745 (UMLS CUI 2011AA)
C0220821 (UMLS CUI 2011AA)
C0006684 (UMLS CUI 2011AA)
373304005 (SNOMED CT 2011_0131)
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