Eligibility NCT00293943 Atrial Fibrillation

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

Eligibility

  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
C0741135 (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)