Criteria Fulfill
Item
subjects must fulfill all of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Paroxysmal atrial fibrillation
Item
1. documented paf:
boolean
C0235480 (UMLS CUI [1])
Paroxysmal atrial fibrillation
Item
diagnosis of paroxysmal atrial fibrillation (paf) (section 9.1.18, general protocol terminology), and
boolean
C0235480 (UMLS CUI [1])
Atrial Fibrillation Episode Quantity ECG tracing
Item
2 or more episodes of af during the 3 months preceding the consent date, at least 1 of which must be documented with a tracing
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2022157 (UMLS CUI [1,4])
Age
Item
2. 18 and 75 years of age
boolean
C0001779 (UMLS CUI [1])
Treatment Effectiveness Lacking Atrial Fibrillation | Therapeutic procedure Paroxysmal atrial fibrillation | Intolerance to Flecainide | Intolerance to Propafenone | Intolerance to Sotalol | Intolerance to dofetilide
Item
3. failure for the treatment of af (effectiveness or intolerance) of one or more of the following drugs indicated in the treatment of paf: flecainide, propafenone, sotalol or dofetilide.
boolean
C0087113 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0235480 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0016229 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0033429 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0037707 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0114771 (UMLS CUI [6,2])
Criteria Fulfill
Item
any of the following is regarded as a criterion for excluding a subject from the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Left atrium Ablation | Exception Retreatment Permission
Item
1. any previous left atrial (la) ablation (except permissible retreatment subjects)
boolean
C0225860 (UMLS CUI [1,1])
C0547070 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0376495 (UMLS CUI [2,2])
C0521104 (UMLS CUI [2,3])
Left atrium Operative Surgical Procedures
Item
2. any previous la surgery
boolean
C0225860 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Intracardiac thrombus
Item
3. current intracardiac thrombus (can be treated after thrombus is resolved)
boolean
C0876998 (UMLS CUI [1])
Pulmonary veins Stent
Item
4. presence of any pulmonary vein stents
boolean
C0034090 (UMLS CUI [1,1])
C0038257 (UMLS CUI [1,2])
Pulmonary Vein Stenosis Pre-existing
Item
5. presence of any pre-existing pulmonary vein stenosis
boolean
C0340756 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Hemidiaphragm Paralysis Pre-existing
Item
6. pre-existing hemidiaphragmatic paralysis
boolean
C1269843 (UMLS CUI [1,1])
C0522224 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
Left atrium Diameter Anteroposterior Transthoracic echocardiography
Item
7. anteroposterior la diameter > 5.5 cm by tte
boolean
C0225860 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C2827723 (UMLS CUI [1,3])
C0430462 (UMLS CUI [1,4])
Heart Valve Prosthesis
Item
8. presence of any cardiac valve prosthesis
boolean
C0018825 (UMLS CUI [1])
Mitral Valve Insufficiency | Mitral Valve Stenosis
Item
9. clinically significant mitral valve regurgitation or stenosis
boolean
C0026266 (UMLS CUI [1])
C0026269 (UMLS CUI [2])
Myocardial Infarction | Percutaneous Coronary Intervention | Percutaneous Transluminal Coronary Angioplasty | Stented coronary artery
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])
C1532338 (UMLS CUI [2])
C2936173 (UMLS CUI [3])
C1272587 (UMLS CUI [4])
Angina, Unstable
Item
11. unstable angina
boolean
C0002965 (UMLS CUI [1])
Cardiac Surgery procedures
Item
12. any cardiac surgery which occurred during the 3 month interval preceding the consent date
boolean
C0018821 (UMLS CUI [1])
Congenital Heart Defects Corrected | Congenital Heart Defects uncorrected | Atrial Septal Defects | Anomalous pulmonary vein | Exception Patent Foramen Ovale Minor
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 [1,1])
C0205202 (UMLS CUI [1,2])
C0018798 (UMLS CUI [2,1])
C4072785 (UMLS CUI [2,2])
C0018817 (UMLS CUI [3])
C0265914 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0016522 (UMLS CUI [5,2])
C0205165 (UMLS CUI [5,3])
Congestive heart failure New York Heart Association Classification
Item
14. nyha class iii or iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
15. left ventricular ejection fraction (lvef) < 40%
boolean
C0428772 (UMLS CUI [1])
Second degree atrioventricular block | Complete atrioventricular block
Item
16. 2º (type ii) or 3º atrioventricular block
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
Permanent pacemaker | Biventricular Pacemakers | Defibrillators Atrial | Implantable defibrillator | Biventricular Pacing
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
C0281945 (UMLS CUI [1])
C1719274 (UMLS CUI [2])
C0180307 (UMLS CUI [3,1])
C0018792 (UMLS CUI [3,2])
C0162589 (UMLS CUI [4])
C2936372 (UMLS CUI [5])
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 Uncontrolled
Item
24. uncontrolled hyperthyroidism
boolean
C0020550 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Cerebral Ischemic Event | Cerebrovascular accident | Transient Ischemic Attack
Item
25. any cerebral ischemic event (strokes or tias) which occurred during the 6 month interval preceding the consent date.
boolean
C0917798 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Pregnancy
Item
26. any woman known to be pregnant
boolean
C0032961 (UMLS CUI [1])
Gender | Pregnancy Absence Lacking
Item
27. any woman without freedom from pregnancy as demonstrated by one or more of the following conditions:
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
HCG pregnancy test Negative
Item
negative β-hcg test within 7 days prior to start date
boolean
C0546577 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Female Sterilization
Item
history of surgical sterilization
boolean
C0015787 (UMLS CUI [1])
Postmenopausal state | Amenorrhea Duration
Item
postmenopausal and free of menses for at least 12 months.
boolean
C0232970 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Life Expectancy
Item
28. life expectancy less than one (1) year
boolean
C0023671 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Biological agents
Item
29. current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C0005515 (UMLS CUI [4])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
30. unwilling or unable to comply fully with study procedures and follow-up
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])