ID

25889

Beschreibung

Continued Access Protocol; ODM derived from: https://clinicaltrials.gov/show/NCT00889681

Link

https://clinicaltrials.gov/show/NCT00889681

Stichworte

Versionen (1)
  1. 25.09.17 25.09.17 -
Hochgeladen am

25. September 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00889681

Englisch

Eligibility Atrial Fibrillation NCT00889681

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must fulfill all of the following criteria:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. documented paf:
Beschreibung

Paroxysmal atrial fibrillation

Datentyp

boolean

Alias
UMLS CUI [1]
C0235480
diagnosis of paroxysmal atrial fibrillation (paf) (section 9.1.18, general protocol terminology), and
Beschreibung

Paroxysmal atrial fibrillation

Datentyp

boolean

Alias
UMLS CUI [1]
C0235480
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
Beschreibung

Atrial Fibrillation Episode Quantity ECG tracing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C2022157
2. 18 and 75 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
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.
Beschreibung

Treatment Effectiveness Lacking Atrial Fibrillation | Therapeutic procedure Paroxysmal atrial fibrillation | Intolerance to Flecainide | Intolerance to Propafenone | Intolerance to Sotalol | Intolerance to dofetilide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087113
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0004238
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0235480
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0016229
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0033429
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0037707
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0114771
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any of the following is regarded as a criterion for excluding a subject from the study:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. any previous left atrial (la) ablation (except permissible retreatment subjects)
Beschreibung

Left atrium Ablation | Exception Retreatment Permission

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0547070
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0376495
UMLS CUI [2,3]
C0521104
2. any previous la surgery
Beschreibung

Left atrium Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0543467
3. current intracardiac thrombus (can be treated after thrombus is resolved)
Beschreibung

Intracardiac thrombus

Datentyp

boolean

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

Pulmonary veins Stent

Datentyp

boolean

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

Pulmonary Vein Stenosis Pre-existing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0340756
UMLS CUI [1,2]
C2347662
6. pre-existing hemidiaphragmatic paralysis
Beschreibung

Hemidiaphragm Paralysis Pre-existing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1269843
UMLS CUI [1,2]
C0522224
UMLS CUI [1,3]
C2347662
7. anteroposterior la diameter > 5.5 cm by tte
Beschreibung

Left atrium Diameter Anteroposterior Transthoracic echocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C2827723
UMLS CUI [1,4]
C0430462
8. presence of any cardiac valve prosthesis
Beschreibung

Heart Valve Prosthesis

Datentyp

boolean

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

Mitral Valve Insufficiency | Mitral Valve Stenosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0026266
UMLS CUI [2]
C0026269
10. myocardial infarction, pci / ptca or coronary artery stenting which occurred during the 3 month interval preceding the consent date
Beschreibung

Myocardial Infarction | Percutaneous Coronary Intervention | Percutaneous Transluminal Coronary Angioplasty | Stented coronary artery

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C1532338
UMLS CUI [3]
C2936173
UMLS CUI [4]
C1272587
11. unstable angina
Beschreibung

Angina, Unstable

Datentyp

boolean

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

Cardiac Surgery procedures

Datentyp

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)
Beschreibung

Congenital Heart Defects Corrected | Congenital Heart Defects uncorrected | Atrial Septal Defects | Anomalous pulmonary vein | Exception Patent Foramen Ovale Minor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018798
UMLS CUI [1,2]
C0205202
UMLS CUI [2,1]
C0018798
UMLS CUI [2,2]
C4072785
UMLS CUI [3]
C0018817
UMLS CUI [4]
C0265914
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0016522
UMLS CUI [5,3]
C0205165
14. nyha class iii or iv congestive heart failure
Beschreibung

Congestive heart failure New York Heart Association Classification

Datentyp

boolean

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

Left ventricular ejection fraction

Datentyp

boolean

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

Second degree atrioventricular block | Complete atrioventricular block

Datentyp

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
17. presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
Beschreibung

Permanent pacemaker | Biventricular Pacemakers | Defibrillators Atrial | Implantable defibrillator | Biventricular Pacing

Datentyp

boolean

Alias
UMLS CUI [1]
C0281945
UMLS CUI [2]
C1719274
UMLS CUI [3,1]
C0180307
UMLS CUI [3,2]
C0018792
UMLS CUI [4]
C0162589
UMLS CUI [5]
C2936372
18. brugada syndrome
Beschreibung

Brugada Syndrome

Datentyp

boolean

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

Long QT Syndrome

Datentyp

boolean

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

Arrhythmogenic Right Ventricular Dysplasia

Datentyp

boolean

Alias
UMLS CUI [1]
C0349788
21. sarcoidosis
Beschreibung

Sarcoidosis

Datentyp

boolean

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

Hypertrophic Cardiomyopathy

Datentyp

boolean

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

Cryoglobulinemia

Datentyp

boolean

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

Hyperthyroidism Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020550
UMLS CUI [1,2]
C0205318
25. any cerebral ischemic event (strokes or tias) which occurred during the 6 month interval preceding the consent date.
Beschreibung

Cerebral Ischemic Event | Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0917798
UMLS CUI [1,2]
C0441471
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
26. any woman known to be pregnant
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
27. any woman without freedom from pregnancy as demonstrated by one or more of the following conditions:
Beschreibung

Gender | Pregnancy Absence Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0332268
negative β-hcg test within 7 days prior to start date
Beschreibung

HCG pregnancy test Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0546577
UMLS CUI [1,2]
C1513916
history of surgical sterilization
Beschreibung

Female Sterilization

Datentyp

boolean

Alias
UMLS CUI [1]
C0015787
postmenopausal and free of menses for at least 12 months.
Beschreibung

Postmenopausal state | Amenorrhea Duration

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
28. life expectancy less than one (1) year
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
29. current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study
Beschreibung

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Biological agents

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4]
C0005515
30. unwilling or unable to comply fully with study procedures and follow-up
Beschreibung

Protocol Compliance Unwilling | Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT00889681

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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