Eligibility Paroxysmal Atrial Fibrillation (PAF) NCT01456949

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StudyEvent: Eligibility
1. Eligibility Paroxysmal Atrial Fibrillation (PAF) NCT01456949

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Paroxysmal Atrial Fibrillation (PAF) NCT01456949