ID

4886

Descrizione

ODM derived from http://clinicaltrials.gov/show/NCT00293943

collegamento

http://clinicaltrials.gov/show/NCT00293943

Keywords

versioni (3)
  1. 06/03/12 06/03/12 -
  2. 13/04/14 13/04/14 - Julian Varghese
  3. 17/09/21 17/09/21 -
Caricato su

13 aprile 2014

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility NCT00293943 Atrial Fibrillation

Tedesco Inglese

Eligibility

1 moduli  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descrizione

Einschlusskriterien

Alter 50 - 85 Jahre
Descrizione

Age

Tipo di dati

boolean

Idiopathic paroxysmal symptomatic atrial fibrillation refractory to antiarrhythmic therapy
Descrizione

atrial fibrillation refractory to antiarrhythmic therapy

Tipo di dati

boolean

Patient willing to participate in randomized trial and an invasive follow-up at month 3 (-6)
Descrizione

Patient participation in trial and follow-up at month 3 (-6)

Tipo di dati

boolean

Structural normal heart
Descrizione

Structural normal heart

Tipo di dati

boolean

Patient willing and able to participate in 12 months follow-up period
Descrizione

Patient participation in 12 months follow-up period

Tipo di dati

boolean

ECG documentation of atrial fibrillation (ECG, Holter, event recorders, etc) for at least one AF event in the prior year (related to symptomatic or asymptomatic episodes) with an average number of one episode per month
Descrizione

ECG documentation of atrial fibrillation

Tipo di dati

boolean

Written informed consent of the patient
Descrizione

informed consent

Tipo di dati

boolean

Ausschlusskriterien
Descrizione

Ausschlusskriterien

Patients who have had previous pulmonary vein ablation procedures. Patients with atrial fibrillation secondary to a reversible cause
Descrizione

Pulmonary vein ablation procedures. Atrial fibrillation secondary to a reversible cause.

Tipo di dati

boolean

Known presence of intracardiac or other thrombi
Descrizione

intracardiac or other thrombi

Tipo di dati

boolean

Evidence of obstructive lung disease requiring bronchodilator therapy
Descrizione

obstructive lung disease requiring broncho-dilator therapy

Tipo di dati

boolean

Pregnant females or those of child bearing potential who have not had a negative pregnancy test within 48 hours before treatment.
Descrizione

Pregnant females or those of child bearing potential who have not had a negative pregnancy test

Tipo di dati

boolean

Other medical illness (i.e. cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than one year)
Descrizione

Other medical illness that may cause the patient to be non-compliant with the protocol

Tipo di dati

boolean

History of bleeding diathesis or suspected pro-coagulant state contraindication to anticoagulation therapy
Descrizione

bleeding diathesis or contraindication to anticoagulation therapy

Tipo di dati

boolean

Hyperthyroidism or hypothyroidism manifested clinically and in laboratory tests (TSH, T3, T4)
Descrizione

Hyperthyroidism or hypothyroidism

Tipo di dati

boolean

Participation in a clinical trial within the last 30 days. Simultaneous participation in a registry (e.g. project AB1 of the AFNET) is permitted.
Descrizione

Participation in a clinical trial within the last 30 days

Tipo di dati

boolean

Drug addiction or chronic alcohol abuse
Descrizione

Drug or alcohol abuse

Tipo di dati

boolean

Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical trial
Descrizione

Legal incapacity

Tipo di dati

boolean

Evidence of an uncooperative attitude
Descrizione

Evidence of an uncooperative attitude

Tipo di dati

boolean

Medizinische Konzepte
Descrizione

Medizinische Konzepte

Alter
Descrizione

Age

Tipo di dati

integer

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
disorder
Descrizione

Disease

Tipo di dati

string

Alias
UMLS CUI
C0012634
SNOMED CT 2010_0731
64572001
Paroxysmal atrial fibrillation
Descrizione

Paroxysmal AF

Tipo di dati

string

Alias
UMLS CUI
C0235480
SNOMED CT 2010_0731
282825002
MedDRA 13.1
10034039
Antiarrhythmic drug
Descrizione

Antiarrhythmic drug

Tipo di dati

string

Alias
UMLS CUI
C0003195
SNOMED CT 2010_0731
67507000
Subject Participation Status in Clinical Study
Descrizione

Study Subject Participation Status

Tipo di dati

string

Alias
UMLS CUI
C2348568
Randomized Clinical Trial
Descrizione

Randomized Clinical Trial

Tipo di dati

string

Alias
UMLS CUI
C0206034
Follow-up
Descrizione

Follow-up

Tipo di dati

string

Alias
UMLS CUI
C1522577
invasiv
Descrizione

Invasive

Tipo di dati

string

Alias
UMLS CUI
C0205281
SNOMED CT 2010_0731
10179008
Herz
Descrizione

Heart

Tipo di dati

string

Alias
UMLS CUI
C0018787
SNOMED CT 2010_0731
80891009
LOINC Version 232
MTHU001067
Elektrokardiogramm (EKG)
Descrizione

ECG

Tipo di dati

string

Alias
UMLS CUI
C1623258
SNOMED CT 2010_0731
46825001
MedDRA 13.1
10014084
Dokumentation
Descrizione

Documentation

Tipo di dati

string

Alias
UMLS CUI
C0920316
Vorhofflimmern
Descrizione

AF

Tipo di dati

string

Alias
UMLS CUI
C0004238
SNOMED CT 2010_0731
49436004
MedDRA 13.1
10003658
ICD-10-CM Version 2010
I48.0
CTCAE Version 4.03
E10081
Holter Electrocardiography
Descrizione

Holter ECG

Tipo di dati

string

Alias
UMLS CUI
C0013801
MedDRA 13.1
10020357
EVENT RECORDER, CARDIAC (IMPLANTABLE)
Descrizione

Event recorder, cardiac

Tipo di dati

string

Alias
UMLS CUI
C0993755
Episode (qualifier value)
Descrizione

Episode

Tipo di dati

string

Alias
UMLS CUI
C0332189
SNOMED CT 2010_0731
272128006
Einverständniserklärung
Descrizione

Informed Consent

Tipo di dati

string

Alias
UMLS CUI
C0021430
Pulmonalvene
Descrizione

Pulmonary veins

Tipo di dati

string

Alias
UMLS CUI
C0034090
SNOMED CT 2010_0731
122972007
LOINC Version 232
MTHU003054
Ablation Therapy
Descrizione

Ablation

Tipo di dati

string

Alias
UMLS CUI
C0547070
SNOMED CT 2010_0731
257729003
Intracardiac thrombus
Descrizione

Intracardiac thrombus

Tipo di dati

string

Alias
UMLS CUI
C0876998
MedDRA 13.1
10048620
Thrombus
Descrizione

Thrombus

Tipo di dati

string

Alias
UMLS CUI
C0087086
SNOMED CT 2010_0731
396339007
obstruktive Lungenerkrankung
Descrizione

Lung Diseases, Obstructive

Tipo di dati

string

Alias
UMLS CUI
C0600260
MedDRA 13.1
10025081
Inhaled bronchodilator therapy
Descrizione

bronchodilator therapy

Tipo di dati

string

Alias
UMLS CUI
C0578554
SNOMED CT 2010_0731
127784009
negativer Schwangerschaftstest
Descrizione

Negative Pregnancy Test

Tipo di dati

string

Alias
UMLS CUI
C0427780
SNOMED CT 2010_0731
250425007
MedDRA 13.1
10036574
Schwangerschaftstest
Descrizione

Pregnancy Tests

Tipo di dati

string

Alias
UMLS CUI
C0032976
SNOMED CT 2010_0731
74036000
MedDRA 13.1
10036572
Krebs
Descrizione

Cancer

Tipo di dati

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
kongestive Herzinsuffizienz
Descrizione

Congestive heart failure

Tipo di dati

string

Alias
UMLS CUI
C0018802
SNOMED CT 2010_0731
42343007
MedDRA 13.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
Life expectancy
Descrizione

Life expectancy

Tipo di dati

string

Alias
UMLS CUI
C0023671
LOINC Version 232
MTHU021387
Blutungsneigung
Descrizione

Bleeding diathesis

Tipo di dati

string

Alias
UMLS CUI
C0005779
SNOMED CT 2010_0731
248250000
MedDRA 13.1
10005134
Kontraindikation
Descrizione

Contraindication

Tipo di dati

string

Alias
UMLS CUI
C1301624
SNOMED CT 2010_0731
397745006
Anticoagulation Therapy
Descrizione

Anticoagulation Therapy

Tipo di dati

string

Alias
UMLS CUI
C0741135
Hyperthyreose
Descrizione

Hyperthyroidism

Tipo di dati

string

Alias
UMLS CUI
C0020550
SNOMED CT 2010_0731
34486009
MedDRA 13.1
10020850
LOINC Version 232
MTHU020782
ICD-10-CM Version 2010
E05.9
ICD-9-CM Version 2011
242.9
CTCAE Version 4.03
E10322
Hypothyreose
Descrizione

Hypothyroidism

Tipo di dati

string

Alias
UMLS CUI
C0020676
SNOMED CT 2010_0731
40930008
MedDRA 13.1
10021114
LOINC Version 232
MTHU020783
ICD-10-CM Version 2010
E03.9
ICD-9-CM Version 2011
244.9
CTCAE Version 4.03
E10334
Registry
Descrizione

Registry

Tipo di dati

string

Alias
UMLS CUI
C0034975
Drogenabhängigkeit
Descrizione

Drug Dependence

Tipo di dati

string

Alias
UMLS CUI
C1510472
SNOMED CT 2010_0731
191816009
MedDRA 13.1
10013663
ICD-9-CM Version 2011
304
chronischer Alkohol-Abusus
Descrizione

Chronic alcohol abuse

Tipo di dati

string

Alias
UMLS CUI
C0001973
SNOMED CT 2010_0731
284591009
MedDRA 13.1
10001639
ICD-10-CM Version 2010
F10.2
ICD-9-CM Version 2011
305.01
Persistent or Significant Disability or Incapacity
Descrizione

SDISAB

Tipo di dati

string

Alias
UMLS CUI
C2347488
Disturbance of understanding
Descrizione

Disturbance of understanding

Tipo di dati

string

Alias
UMLS CUI
C0233825
SNOMED CT 2010_0731
64270008
nicht-kooperatives Verhalten
Descrizione

Uncooperative

Tipo di dati

string

Alias
UMLS CUI
C0424350
SNOMED CT 2010_0731
248042003
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Similar models

Eligibility

1 moduli
  1. StudyEvent: Eligibility
    1. Eligibility
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Einschlusskriterien
Age
Item
Alter 50 - 85 Jahre
boolean
atrial fibrillation refractory to antiarrhythmic therapy
Item
Idiopathic paroxysmal symptomatic atrial fibrillation refractory to antiarrhythmic therapy
boolean
Patient participation in trial and follow-up at month 3 (-6)
Item
Patient willing to participate in randomized trial and an invasive follow-up at month 3 (-6)
boolean
Structural normal heart
Item
Structural normal heart
boolean
Patient participation in 12 months follow-up period
Item
Patient willing and able to participate in 12 months follow-up period
boolean
ECG documentation of atrial fibrillation
Item
ECG documentation of atrial fibrillation (ECG, Holter, event recorders, etc) for at least one AF event in the prior year (related to symptomatic or asymptomatic episodes) with an average number of one episode per month
boolean
informed consent
Item
Written informed consent of the patient
boolean
Item Group
Ausschlusskriterien
Pulmonary vein ablation procedures. Atrial fibrillation secondary to a reversible cause.
Item
Patients who have had previous pulmonary vein ablation procedures. Patients with atrial fibrillation secondary to a reversible cause
boolean
intracardiac or other thrombi
Item
Known presence of intracardiac or other thrombi
boolean
obstructive lung disease requiring broncho-dilator therapy
Item
Evidence of obstructive lung disease requiring bronchodilator therapy
boolean
Pregnant females or those of child bearing potential who have not had a negative pregnancy test
Item
Pregnant females or those of child bearing potential who have not had a negative pregnancy test within 48 hours before treatment.
boolean
Other medical illness that may cause the patient to be non-compliant with the protocol
Item
Other medical illness (i.e. cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than one year)
boolean
bleeding diathesis or contraindication to anticoagulation therapy
Item
History of bleeding diathesis or suspected pro-coagulant state contraindication to anticoagulation therapy
boolean
Hyperthyroidism or hypothyroidism
Item
Hyperthyroidism or hypothyroidism manifested clinically and in laboratory tests (TSH, T3, T4)
boolean
Participation in a clinical trial within the last 30 days
Item
Participation in a clinical trial within the last 30 days. Simultaneous participation in a registry (e.g. project AB1 of the AFNET) is permitted.
boolean
Drug or alcohol abuse
Item
Drug addiction or chronic alcohol abuse
boolean
Legal incapacity
Item
Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical trial
boolean
Evidence of an uncooperative attitude
Item
Evidence of an uncooperative attitude
boolean
Item Group
Medizinische Konzepte
Age
Item
Alter
integer
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Disease
Item
disorder
string
C0012634 (UMLS CUI)
64572001 (SNOMED CT 2010_0731)
Paroxysmal AF
Item
Paroxysmal atrial fibrillation
string
C0235480 (UMLS CUI)
282825002 (SNOMED CT 2010_0731)
10034039 (MedDRA 13.1)
Antiarrhythmic drug
Item
Antiarrhythmic drug
string
C0003195 (UMLS CUI)
67507000 (SNOMED CT 2010_0731)
Study Subject Participation Status
Item
Subject Participation Status in Clinical Study
string
C2348568 (UMLS CUI)
Randomized Clinical Trial
Item
Randomized Clinical Trial
string
C0206034 (UMLS CUI)
Follow-up
Item
Follow-up
string
C1522577 (UMLS CUI)
Invasive
Item
invasiv
string
C0205281 (UMLS CUI)
10179008 (SNOMED CT 2010_0731)
Heart
Item
Herz
string
C0018787 (UMLS CUI)
80891009 (SNOMED CT 2010_0731)
MTHU001067 (LOINC Version 232)
ECG
Item
Elektrokardiogramm (EKG)
string
C1623258 (UMLS CUI)
46825001 (SNOMED CT 2010_0731)
10014084 (MedDRA 13.1)
Documentation
Item
Dokumentation
string
C0920316 (UMLS CUI)
AF
Item
Vorhofflimmern
string
C0004238 (UMLS CUI)
49436004 (SNOMED CT 2010_0731)
10003658 (MedDRA 13.1)
I48.0 (ICD-10-CM Version 2010)
E10081 (CTCAE Version 4.03)
Holter ECG
Item
Holter Electrocardiography
string
C0013801 (UMLS CUI)
10020357 (MedDRA 13.1)
Event recorder, cardiac
Item
EVENT RECORDER, CARDIAC (IMPLANTABLE)
string
C0993755 (UMLS CUI)
Episode
Item
Episode (qualifier value)
string
C0332189 (UMLS CUI)
272128006 (SNOMED CT 2010_0731)
Informed Consent
Item
Einverständniserklärung
string
C0021430 (UMLS CUI)
Pulmonary veins
Item
Pulmonalvene
string
C0034090 (UMLS CUI)
122972007 (SNOMED CT 2010_0731)
MTHU003054 (LOINC Version 232)
Ablation
Item
Ablation Therapy
string
C0547070 (UMLS CUI)
257729003 (SNOMED CT 2010_0731)
Intracardiac thrombus
Item
Intracardiac thrombus
string
C0876998 (UMLS CUI)
10048620 (MedDRA 13.1)
Thrombus
Item
Thrombus
string
C0087086 (UMLS CUI)
396339007 (SNOMED CT 2010_0731)
Lung Diseases, Obstructive
Item
obstruktive Lungenerkrankung
string
C0600260 (UMLS CUI)
10025081 (MedDRA 13.1)
bronchodilator therapy
Item
Inhaled bronchodilator therapy
string
C0578554 (UMLS CUI)
127784009 (SNOMED CT 2010_0731)
Negative Pregnancy Test
Item
negativer Schwangerschaftstest
string
C0427780 (UMLS CUI)
250425007 (SNOMED CT 2010_0731)
10036574 (MedDRA 13.1)
Pregnancy Tests
Item
Schwangerschaftstest
string
C0032976 (UMLS CUI)
74036000 (SNOMED CT 2010_0731)
10036572 (MedDRA 13.1)
Cancer
Item
Krebs
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Congestive heart failure
Item
kongestive Herzinsuffizienz
string
C0018802 (UMLS CUI)
42343007 (SNOMED CT 2010_0731)
10007559 (MedDRA 13.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
Life expectancy
Item
Life expectancy
string
C0023671 (UMLS CUI)
MTHU021387 (LOINC Version 232)
Bleeding diathesis
Item
Blutungsneigung
string
C0005779 (UMLS CUI)
248250000 (SNOMED CT 2010_0731)
10005134 (MedDRA 13.1)
Contraindication
Item
Kontraindikation
string
C1301624 (UMLS CUI)
397745006 (SNOMED CT 2010_0731)
Anticoagulation Therapy
Item
Anticoagulation Therapy
string
C0741135 (UMLS CUI)
Hyperthyroidism
Item
Hyperthyreose
string
C0020550 (UMLS CUI)
34486009 (SNOMED CT 2010_0731)
10020850 (MedDRA 13.1)
MTHU020782 (LOINC Version 232)
E05.9 (ICD-10-CM Version 2010)
242.9 (ICD-9-CM Version 2011)
E10322 (CTCAE Version 4.03)
Hypothyroidism
Item
Hypothyreose
string
C0020676 (UMLS CUI)
40930008 (SNOMED CT 2010_0731)
10021114 (MedDRA 13.1)
MTHU020783 (LOINC Version 232)
E03.9 (ICD-10-CM Version 2010)
244.9 (ICD-9-CM Version 2011)
E10334 (CTCAE Version 4.03)
Registry
Item
Registry
string
C0034975 (UMLS CUI)
Drug Dependence
Item
Drogenabhängigkeit
string
C1510472 (UMLS CUI)
191816009 (SNOMED CT 2010_0731)
10013663 (MedDRA 13.1)
304 (ICD-9-CM Version 2011)
Chronic alcohol abuse
Item
chronischer Alkohol-Abusus
string
C0001973 (UMLS CUI)
284591009 (SNOMED CT 2010_0731)
10001639 (MedDRA 13.1)
F10.2 (ICD-10-CM Version 2010)
305.01 (ICD-9-CM Version 2011)
SDISAB
Item
Persistent or Significant Disability or Incapacity
string
C2347488 (UMLS CUI)
Disturbance of understanding
Item
Disturbance of understanding
string
C0233825 (UMLS CUI)
64270008 (SNOMED CT 2010_0731)
Uncooperative
Item
nicht-kooperatives Verhalten
string
C0424350 (UMLS CUI)
248042003 (SNOMED CT 2010_0731)
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