ID

13783

Description

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

Keywords

Versions (1)
  1. 3/6/16 3/6/16 -
Uploaded on

March 6, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Paroxysmal Atrial Fibrillation (PAF) NCT01456949

English

Eligibility Paroxysmal Atrial Fibrillation (PAF) NCT01456949

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. documented paf:
Description

Paroxysmal Atrial Fibrillation

Data type

boolean

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

Paroxysmal Atrial Fibrillation

Data type

boolean

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

Episode of Paroxysmal Atrial Fibrillation

Data type

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.
Description

Episode of Paroxysmal Atrial Fibrillation

Data type

boolean

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

age

Data type

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.
Description

Unresponsive to Treatment Atrial Fibrillation

Data type

boolean

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

Exclusion Criteria

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

Atrial Ablation left

Data type

boolean

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

surgery atria Left

Data type

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)
Description

intracardiac thrombus

Data type

boolean

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

stent Pulmonary veins

Data type

boolean

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

pulmonary vein stenosis

Data type

boolean

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

Respiratory Paralysis diaphragm

Data type

boolean

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

diameter atria Left

Data type

boolean

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

cardiac valve prosthesis

Data type

boolean

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

mitral valve stenosis

Data type

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
Description

myocardial infarction; coronary artery stenting

Data type

boolean

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

unstable angina

Data type

boolean

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

cardiac surgery

Data type

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)
Description

congenital heart defect; atrial septal defects; pulmonary vein abnormalities

Data type

boolean

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

nyha class; congestive heart failure

Data type

boolean

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

left ventricular ejection fraction

Data type

boolean

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

atrioventricular block

Data type

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)
Description

permanent pacemaker; cardiac defibrillator

Data type

boolean

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

brugada syndrome

Data type

boolean

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

long qt syndrome

Data type

boolean

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

arrhythmogenic right ventricular dysplasia

Data type

boolean

Alias
UMLS CUI [1]
C0349788
21. sarcoidosis
Description

sarcoidosis

Data type

boolean

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

hypertrophic cardiomyopathy

Data type

boolean

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

cryoglobulinemia

Data type

boolean

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

hyperthyroidism

Data type

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.
Description

Transient Ischemic Attack

Data type

boolean

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

pregnancy

Data type

boolean

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

life expectancy

Data type

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
Description

Study Subject Participation Status

Data type

boolean

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

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Back to the top of the page

Similar models

Eligibility Paroxysmal Atrial Fibrillation (PAF) NCT01456949

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial