ID

13783

Beschrijving

Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS); ODM derived from: https://clinicaltrials.gov/show/NCT01456949

Link

https://clinicaltrials.gov/show/NCT01456949

Trefwoorden

Versies (1)
  1. 06-03-16 06-03-16 -
Geüploaded op

6 maart 2016

DOI

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Creative Commons BY 4.0
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Eligibility Paroxysmal Atrial Fibrillation (PAF) NCT01456949

Engels

Eligibility Paroxysmal Atrial Fibrillation (PAF) NCT01456949

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. documented paf:
Beschrijving

Paroxysmal Atrial Fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C0235480
diagnosis of paroxysmal atrial fibrillation (paf), and
Beschrijving

Paroxysmal Atrial Fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C0235480
2 or more episodes of af during the 3 months preceding the consent date, and
Beschrijving

Episode of Paroxysmal Atrial Fibrillation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0235480
at least 1 episode of af documented with a tracing within 12 months preceding the consent date.
Beschrijving

Episode of Paroxysmal Atrial Fibrillation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C0235480
2. age 18 years or older
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. failure for the treatment of af (effectiveness or intolerance) of at least one membrane active aad for rhythm control.
Beschrijving

Unresponsive to Treatment Atrial Fibrillation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205269
UMLS CUI [1,2]
C0004238
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any previous left atrial (la) ablation (except permissible retreatment subjects)
Beschrijving

Atrial Ablation left

Datatype

boolean

Alias
UMLS CUI [1,1]
C2825182
UMLS CUI [1,2]
C0205091
2. any previous la surgery
Beschrijving

surgery atria Left

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0018792
UMLS CUI [1,3]
C0205091
3. current intracardiac thrombus (can be treated after thrombus is resolved)
Beschrijving

intracardiac thrombus

Datatype

boolean

Alias
UMLS CUI [1]
C0876998
4. presence of any pulmonary vein stents
Beschrijving

stent Pulmonary veins

Datatype

boolean

Alias
UMLS CUI [1,1]
C0038257
UMLS CUI [1,2]
C0034090
5. presence of any pre-existing pulmonary vein stenosis
Beschrijving

pulmonary vein stenosis

Datatype

boolean

Alias
UMLS CUI [1]
C0340756
6. pre-existing hemidiaphragmatic paralysis
Beschrijving

Respiratory Paralysis diaphragm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035232
UMLS CUI [1,2]
C0011980
7. anteroposterior la diameter > 5.5 cm by tte
Beschrijving

diameter atria Left

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301886
UMLS CUI [1,2]
C0018792
UMLS CUI [1,3]
C0205091
8. presence of any cardiac valve prosthesis
Beschrijving

cardiac valve prosthesis

Datatype

boolean

Alias
UMLS CUI [1]
C0018825
9. clinically significant mitral valve regurgitation or stenosis
Beschrijving

mitral valve stenosis

Datatype

boolean

Alias
UMLS CUI [1]
C0026269
10. myocardial infarction, pci / ptca or coronary artery stenting which occurred during the 3 month interval preceding the consent date
Beschrijving

myocardial infarction; coronary artery stenting

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C1272587
11. unstable angina
Beschrijving

unstable angina

Datatype

boolean

Alias
UMLS CUI [1]
C0002965
12. any cardiac surgery which occurred during the 3 month interval preceding the consent date
Beschrijving

cardiac surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0018821
13. any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor pfo)
Beschrijving

congenital heart defect; atrial septal defects; pulmonary vein abnormalities

Datatype

boolean

Alias
UMLS CUI [1]
C0018798
UMLS CUI [2]
C0018817
UMLS CUI [3]
C1290492
14. nyha class iii or iv congestive heart failure
Beschrijving

nyha class; congestive heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C0018802
15. left ventricular ejection fraction (lvef) < 40%
Beschrijving

left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
16. 2º (type ii) or 3º atrioventricular block
Beschrijving

atrioventricular block

Datatype

boolean

Alias
UMLS CUI [1]
C0004245
17. presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
Beschrijving

permanent pacemaker; cardiac defibrillator

Datatype

boolean

Alias
UMLS CUI [1]
C0455666
UMLS CUI [2]
C1391956
18. brugada syndrome
Beschrijving

brugada syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C1142166
19. long qt syndrome
Beschrijving

long qt syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0023976
20. arrhythmogenic right ventricular dysplasia
Beschrijving

arrhythmogenic right ventricular dysplasia

Datatype

boolean

Alias
UMLS CUI [1]
C0349788
21. sarcoidosis
Beschrijving

sarcoidosis

Datatype

boolean

Alias
UMLS CUI [1]
C0036202
22. hypertrophic cardiomyopathy
Beschrijving

hypertrophic cardiomyopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0007194
23. known cryoglobulinemia
Beschrijving

cryoglobulinemia

Datatype

boolean

Alias
UMLS CUI [1]
C0010403
24. uncontrolled hyperthyroidism
Beschrijving

hyperthyroidism

Datatype

boolean

Alias
UMLS CUI [1]
C0020550
25. any cerebral ischemic event (strokes or tias) which occurred during the 6 month interval preceding the consent date.
Beschrijving

Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0007787
26. any woman known to be pregnant
Beschrijving

pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
27. life expectancy less than one (1) year
Beschrijving

life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
28. current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by medtronic
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
29. unwilling or unable to comply fully with study procedures and followup
Beschrijving

compliance

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Paroxysmal Atrial Fibrillation (PAF) NCT01456949

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal Atrial Fibrillation
Item
1. documented paf:
boolean
C0235480 (UMLS CUI [1])
Paroxysmal Atrial Fibrillation
Item
diagnosis of paroxysmal atrial fibrillation (paf), and
boolean
C0235480 (UMLS CUI [1])
Episode of Paroxysmal Atrial Fibrillation
Item
2 or more episodes of af during the 3 months preceding the consent date, and
boolean
C0332189 (UMLS CUI [1,1])
C0235480 (UMLS CUI [1,2])
Episode of Paroxysmal Atrial Fibrillation
Item
at least 1 episode of af documented with a tracing within 12 months preceding the consent date.
boolean
C0332189 (UMLS CUI [1,1])
C0235480 (UMLS CUI [1,2])
age
Item
2. age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Unresponsive to Treatment Atrial Fibrillation
Item
3. failure for the treatment of af (effectiveness or intolerance) of at least one membrane active aad for rhythm control.
boolean
C0205269 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Atrial Ablation left
Item
1. any previous left atrial (la) ablation (except permissible retreatment subjects)
boolean
C2825182 (UMLS CUI [1,1])
C0205091 (UMLS CUI [1,2])
surgery atria Left
Item
2. any previous la surgery
boolean
C0543467 (UMLS CUI [1,1])
C0018792 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
intracardiac thrombus
Item
3. current intracardiac thrombus (can be treated after thrombus is resolved)
boolean
C0876998 (UMLS CUI [1])
stent Pulmonary veins
Item
4. presence of any pulmonary vein stents
boolean
C0038257 (UMLS CUI [1,1])
C0034090 (UMLS CUI [1,2])
pulmonary vein stenosis
Item
5. presence of any pre-existing pulmonary vein stenosis
boolean
C0340756 (UMLS CUI [1])
Respiratory Paralysis diaphragm
Item
6. pre-existing hemidiaphragmatic paralysis
boolean
C0035232 (UMLS CUI [1,1])
C0011980 (UMLS CUI [1,2])
diameter atria Left
Item
7. anteroposterior la diameter > 5.5 cm by tte
boolean
C1301886 (UMLS CUI [1,1])
C0018792 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
cardiac valve prosthesis
Item
8. presence of any cardiac valve prosthesis
boolean
C0018825 (UMLS CUI [1])
mitral valve stenosis
Item
9. clinically significant mitral valve regurgitation or stenosis
boolean
C0026269 (UMLS CUI [1])
myocardial infarction; coronary artery stenting
Item
10. myocardial infarction, pci / ptca or coronary artery stenting which occurred during the 3 month interval preceding the consent date
boolean
C0027051 (UMLS CUI [1])
C1272587 (UMLS CUI [2])
unstable angina
Item
11. unstable angina
boolean
C0002965 (UMLS CUI [1])
cardiac surgery
Item
12. any cardiac surgery which occurred during the 3 month interval preceding the consent date
boolean
C0018821 (UMLS CUI [1])
congenital heart defect; atrial septal defects; pulmonary vein abnormalities
Item
13. any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor pfo)
boolean
C0018798 (UMLS CUI [1])
C0018817 (UMLS CUI [2])
C1290492 (UMLS CUI [3])
nyha class; congestive heart failure
Item
14. nyha class iii or iv congestive heart failure
boolean
C1275491 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
left ventricular ejection fraction
Item
15. left ventricular ejection fraction (lvef) < 40%
boolean
C0428772 (UMLS CUI [1])
atrioventricular block
Item
16. 2º (type ii) or 3º atrioventricular block
boolean
C0004245 (UMLS CUI [1])
permanent pacemaker; cardiac defibrillator
Item
17. presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
boolean
C0455666 (UMLS CUI [1])
C1391956 (UMLS CUI [2])
brugada syndrome
Item
18. brugada syndrome
boolean
C1142166 (UMLS CUI [1])
long qt syndrome
Item
19. long qt syndrome
boolean
C0023976 (UMLS CUI [1])
arrhythmogenic right ventricular dysplasia
Item
20. arrhythmogenic right ventricular dysplasia
boolean
C0349788 (UMLS CUI [1])
sarcoidosis
Item
21. sarcoidosis
boolean
C0036202 (UMLS CUI [1])
hypertrophic cardiomyopathy
Item
22. hypertrophic cardiomyopathy
boolean
C0007194 (UMLS CUI [1])
cryoglobulinemia
Item
23. known cryoglobulinemia
boolean
C0010403 (UMLS CUI [1])
hyperthyroidism
Item
24. uncontrolled hyperthyroidism
boolean
C0020550 (UMLS CUI [1])
Transient Ischemic Attack
Item
25. any cerebral ischemic event (strokes or tias) which occurred during the 6 month interval preceding the consent date.
boolean
C0007787 (UMLS CUI [1])
pregnancy
Item
26. any woman known to be pregnant
boolean
C0032961 (UMLS CUI [1])
life expectancy
Item
27. life expectancy less than one (1) year
boolean
C0023671 (UMLS CUI [1])
Study Subject Participation Status
Item
28. current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by medtronic
boolean
C2348568 (UMLS CUI [1])
compliance
Item
29. unwilling or unable to comply fully with study procedures and followup
boolean
C1321605 (UMLS CUI [1])
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