ID

43055

Description

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

Link

http://clinicaltrials.gov/show/NCT00293943

Keywords

Versions (3)
  1. 3/6/12 3/6/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
  3. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

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 NCT00293943 Atrial Fibrillation

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Age 50 - 85 years
Description

Age

Data type

boolean

Idiopathic paroxysmal symptomatic atrial fibrillation refractory to antiarrhythmic therapy
Description

atrial fibrillation refractory to antiarrhythmic therapy

Data type

boolean

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

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

Data type

boolean

Structural normal heart
Description

Structural normal heart

Data type

boolean

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

Patient participation in 12 months follow-up period

Data type

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
Description

ECG documentation of atrial fibrillation

Data type

boolean

Written informed consent of the patient
Description

informed consent

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

boolean

Known presence of intracardiac or other thrombi
Description

intracardiac or other thrombi

Data type

boolean

Evidence of obstructive lung disease requiring bronchodilator therapy
Description

obstructive lung disease requiring broncho-dilator therapy

Data type

boolean

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

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

Data type

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)
Description

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

Data type

boolean

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

bleeding diathesis or contraindication to anticoagulation therapy

Data type

boolean

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

Hyperthyroidism or hypothyroidism

Data type

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.
Description

Participation in a clinical trial within the last 30 days

Data type

boolean

Drug addiction or chronic alcohol abuse
Description

Drug or alcohol abuse

Data type

boolean

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

Legal incapacity

Data type

boolean

Evidence of an uncooperative attitude
Description

Evidence of an uncooperative attitude

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

integer

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
disorder
Description

Disease

Data type

string

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

Paroxysmal AF

Data type

string

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

Antiarrhythmic drug

Data type

string

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

Study Subject Participation Status

Data type

string

Alias
UMLS CUI
C2348568
Randomized Clinical Trial
Description

Randomized Clinical Trial

Data type

string

Alias
UMLS CUI
C0206034
Follow-up
Description

Follow-up

Data type

string

Alias
UMLS CUI
C1522577
Invasive (qualifier value)
Description

Invasive

Data type

string

Alias
UMLS CUI
C0205281
SNOMED CT 2010_0731
10179008
Heart structure
Description

Heart

Data type

string

Alias
UMLS CUI
C0018787
SNOMED CT 2010_0731
80891009
LOINC Version 232
MTHU001067
Electrocardiogram
Description

ECG

Data type

string

Alias
UMLS CUI
C1623258
SNOMED CT 2010_0731
46825001
MedDRA 13.1
10014084
Documentation
Description

Documentation

Data type

string

Alias
UMLS CUI
C0920316
Atrial fibrillation
Description

AF

Data type

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
Description

Holter ECG

Data type

string

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

Event recorder, cardiac

Data type

string

Alias
UMLS CUI
C0993755
Episode (qualifier value)
Description

Episode

Data type

string

Alias
UMLS CUI
C0332189
SNOMED CT 2010_0731
272128006
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
Pulmonary venous structure
Description

Pulmonary veins

Data type

string

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

Ablation

Data type

string

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

Intracardiac thrombus

Data type

string

Alias
UMLS CUI
C0876998
MedDRA 13.1
10048620
Thrombus
Description

Thrombus

Data type

string

Alias
UMLS CUI
C0087086
SNOMED CT 2010_0731
396339007
Lung Diseases, Obstructive
Description

Lung Diseases, Obstructive

Data type

string

Alias
UMLS CUI
C0600260
MedDRA 13.1
10025081
Inhaled bronchodilator therapy
Description

bronchodilator therapy

Data type

string

Alias
UMLS CUI
C0578554
SNOMED CT 2010_0731
127784009
Negative Pregnancy Test
Description

Negative Pregnancy Test

Data type

string

Alias
UMLS CUI
C0427780
SNOMED CT 2010_0731
250425007
MedDRA 13.1
10036574
Pregnancy detection examination
Description

Pregnancy Tests

Data type

string

Alias
UMLS CUI
C0032976
SNOMED CT 2010_0731
74036000
MedDRA 13.1
10036572
Malignant Neoplasms
Description

Cancer

Data type

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
Congestive heart failure
Description

Congestive heart failure

Data type

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
Description

Life expectancy

Data type

string

Alias
UMLS CUI
C0023671
LOINC Version 232
MTHU021387
Bleeding tendency
Description

Bleeding diathesis

Data type

string

Alias
UMLS CUI
C0005779
SNOMED CT 2010_0731
248250000
MedDRA 13.1
10005134
Medical Contraindication
Description

Contraindication

Data type

string

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

Anticoagulation Therapy

Data type

string

Alias
UMLS CUI
C0003281
Hyperthyroidism
Description

Hyperthyroidism

Data type

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
Hypothyroidism
Description

Hypothyroidism

Data type

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
Description

Registry

Data type

string

Alias
UMLS CUI
C0034975
Drug addiction
Description

Drug Dependence

Data type

string

Alias
UMLS CUI
C1510472
SNOMED CT 2010_0731
191816009
MedDRA 13.1
10013663
ICD-9-CM Version 2011
304
Alcoholic Intoxication, Chronic
Description

Chronic alcohol abuse

Data type

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
Description

SDISAB

Data type

string

Alias
UMLS CUI
C2347488
Disturbance of understanding
Description

Disturbance of understanding

Data type

string

Alias
UMLS CUI
C0233825
SNOMED CT 2010_0731
64270008
Uncooperative behavior
Description

Uncooperative

Data type

string

Alias
UMLS CUI
C0424350
SNOMED CT 2010_0731
248042003
Back to the top of the page

Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
Age 50 - 85 years
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
Exclusion Criteria
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
Medical Concepts
Age
Item
Age
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
Invasive (qualifier value)
string
C0205281 (UMLS CUI)
10179008 (SNOMED CT 2010_0731)
Heart
Item
Heart structure
string
C0018787 (UMLS CUI)
80891009 (SNOMED CT 2010_0731)
MTHU001067 (LOINC Version 232)
ECG
Item
Electrocardiogram
string
C1623258 (UMLS CUI)
46825001 (SNOMED CT 2010_0731)
10014084 (MedDRA 13.1)
Documentation
Item
Documentation
string
C0920316 (UMLS CUI)
AF
Item
Atrial fibrillation
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
Informed Consent
string
C0021430 (UMLS CUI)
Pulmonary veins
Item
Pulmonary venous structure
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
Lung Diseases, Obstructive
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
Negative Pregnancy Test
string
C0427780 (UMLS CUI)
250425007 (SNOMED CT 2010_0731)
10036574 (MedDRA 13.1)
Pregnancy Tests
Item
Pregnancy detection examination
string
C0032976 (UMLS CUI)
74036000 (SNOMED CT 2010_0731)
10036572 (MedDRA 13.1)
Cancer
Item
Malignant Neoplasms
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
Congestive heart failure
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
Bleeding tendency
string
C0005779 (UMLS CUI)
248250000 (SNOMED CT 2010_0731)
10005134 (MedDRA 13.1)
Contraindication
Item
Medical Contraindication
string
C1301624 (UMLS CUI)
397745006 (SNOMED CT 2010_0731)
Anticoagulation Therapy
Item
Anticoagulation Therapy
string
C0003281 (UMLS CUI)
Hyperthyroidism
Item
Hyperthyroidism
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
Hypothyroidism
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
Drug addiction
string
C1510472 (UMLS CUI)
191816009 (SNOMED CT 2010_0731)
10013663 (MedDRA 13.1)
304 (ICD-9-CM Version 2011)
Chronic alcohol abuse
Item
Alcoholic Intoxication, Chronic
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
Uncooperative behavior
string
C0424350 (UMLS CUI)
248042003 (SNOMED CT 2010_0731)
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