ID

20987

Beschrijving

Treatment of Atrial Fibrillation by Minimal Invasive Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00448656

Link

https://clinicaltrials.gov/show/NCT00448656

Trefwoorden

Versies (1)
  1. 02-04-17 02-04-17 -
Geüploaded op

2 april 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00448656

Engels

Eligibility Atrial Fibrillation NCT00448656

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. documented symptomatic lone paroxysmal or persistent atrial fibrillation, which either convert spontaneously or can be terminated with antiarrhythmic drugs or by an electrical cardioversion.
Beschrijving

atrial fibrillation converting spontaneously, by antiarrhythmic drugs or by electrical cardioversion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0439836
UMLS CUI [1,3]
C0205359
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C1283212
UMLS CUI [2,3]
C0003195
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C1283212
UMLS CUI [3,3]
C0013778
2. the patient had a least one episode of persistent atrial fibrillation or three episodes of paroxysmal atrial fibrillation during the last three months.
Beschrijving

persistent or paroxysmal atrial fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2]
C0235480
3. duration present episode persistent atrial fibrillation less then one year.
Beschrijving

persistent atrial fibrillation duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C2585653
UMLS CUI [1,2]
C0449238
4. the patient has been treated with at least two different antiarrhythmic drugs (class i-iv) of which at least one belongs to class i or iii.
Beschrijving

treatment with antiarrhythmic drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0003195
UMLS CUI [1,3]
C0008902
5. the patient will sign and date the written informed consent prior to study participation.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. age <18 and >76 years.
Beschrijving

ID.6

Datatype

boolean

2. contraindications for oral anticoagulation.
Beschrijving

oral anticoagulation contraindication

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1272919
UMLS CUI [1,3]
C0522473
3. signs of sick sinus syndrome or av conduction disturbances (i.e. symptomatic bradycardia or asystole > 3 seconds or escape rate < 40 beats per minute in awake symptom-free patients).
Beschrijving

signs of sick sinus syndrome or av conduction disturbance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0037052
UMLS CUI [1,2]
C0037088
UMLS CUI [2]
C0004245
4. permanent atrial fibrillation defined as atrial fibrillation continuously present and not convertible to sinus rhythm by an electrical cardioversion or antiarrhythmic drugs.
Beschrijving

permanent atrial fibrillation not convertible

Datatype

boolean

Alias
UMLS CUI [1]
C2586056
5. previous transvenous pulmonary vein isolation, maze surgery, or other cardiac surgery.
Beschrijving

transvenous pulmonary veis isolation, maze surgery or other cardiac surgery

Datatype

boolean

Alias
UMLS CUI [1]
C3544330
UMLS CUI [2]
C0397414
UMLS CUI [3]
C0018821
6. heart failure defined as nyha class iii-iv heart failure.
Beschrijving

heart failure nyha iii-iv

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0278962
7. previously implanted intracardiac device or has current or foreseen pacemaker, internal cardioverter defibrillator (icd) and/ or cardiac resynchronization therapy.
Beschrijving

implanted intracardiac device

Datatype

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0162589
UMLS CUI [3]
C1167956
8. clinically relevant valvular heart disease.
Beschrijving

valvular heart disease

Datatype

boolean

Alias
UMLS CUI [1]
C0018824
9. coronary artery disease or an old myocardial infarction
Beschrijving

coronary artery disease or myocardial infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2]
C0027051
10. acute or chronic infection.
Beschrijving

acute or chronic infection

Datatype

boolean

Alias
UMLS CUI [1]
C0275518
UMLS CUI [2]
C0151317
11. untreated clinical hypo- or hyperthyroidism or < 3 months euthyroidism.
Beschrijving

hypothyroidism or hyperthyroidism

Datatype

boolean

Alias
UMLS CUI [1]
C0020676
UMLS CUI [2]
C0020550
12. uncontrolled hypertension, defined as a systolic blood pressure > 160 mm hg and/or a diastolic blood pressure > 95 mm hg (anti-hypertensive treatment is allowed).
Beschrijving

uncontrolled arterial hypertension

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0205318
13. the patient has a concurrent medical condition (i.e. alcohol or drug abuse or a severe progressive extracardiac disease) or is unlikely to comply with the protocol.
Beschrijving

comorbidity, compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C1321605
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Similar models

Eligibility Atrial Fibrillation NCT00448656

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
atrial fibrillation converting spontaneously, by antiarrhythmic drugs or by electrical cardioversion
Item
1. documented symptomatic lone paroxysmal or persistent atrial fibrillation, which either convert spontaneously or can be terminated with antiarrhythmic drugs or by an electrical cardioversion.
boolean
C0004238 (UMLS CUI [1,1])
C0439836 (UMLS CUI [1,2])
C0205359 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2,1])
C1283212 (UMLS CUI [2,2])
C0003195 (UMLS CUI [2,3])
C0004238 (UMLS CUI [3,1])
C1283212 (UMLS CUI [3,2])
C0013778 (UMLS CUI [3,3])
persistent or paroxysmal atrial fibrillation
Item
2. the patient had a least one episode of persistent atrial fibrillation or three episodes of paroxysmal atrial fibrillation during the last three months.
boolean
C2585653 (UMLS CUI [1])
C0235480 (UMLS CUI [2])
persistent atrial fibrillation duration
Item
3. duration present episode persistent atrial fibrillation less then one year.
boolean
C2585653 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
treatment with antiarrhythmic drug
Item
4. the patient has been treated with at least two different antiarrhythmic drugs (class i-iv) of which at least one belongs to class i or iii.
boolean
C0013216 (UMLS CUI [1,1])
C0003195 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
informed consent
Item
5. the patient will sign and date the written informed consent prior to study participation.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.6
Item
1. age <18 and >76 years.
boolean
oral anticoagulation contraindication
Item
2. contraindications for oral anticoagulation.
boolean
C0003281 (UMLS CUI [1,1])
C1272919 (UMLS CUI [1,2])
C0522473 (UMLS CUI [1,3])
signs of sick sinus syndrome or av conduction disturbance
Item
3. signs of sick sinus syndrome or av conduction disturbances (i.e. symptomatic bradycardia or asystole > 3 seconds or escape rate < 40 beats per minute in awake symptom-free patients).
boolean
C0037052 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C0004245 (UMLS CUI [2])
permanent atrial fibrillation not convertible
Item
4. permanent atrial fibrillation defined as atrial fibrillation continuously present and not convertible to sinus rhythm by an electrical cardioversion or antiarrhythmic drugs.
boolean
C2586056 (UMLS CUI [1])
transvenous pulmonary veis isolation, maze surgery or other cardiac surgery
Item
5. previous transvenous pulmonary vein isolation, maze surgery, or other cardiac surgery.
boolean
C3544330 (UMLS CUI [1])
C0397414 (UMLS CUI [2])
C0018821 (UMLS CUI [3])
heart failure nyha iii-iv
Item
6. heart failure defined as nyha class iii-iv heart failure.
boolean
C0018801 (UMLS CUI [1,1])
C0278962 (UMLS CUI [1,2])
implanted intracardiac device
Item
7. previously implanted intracardiac device or has current or foreseen pacemaker, internal cardioverter defibrillator (icd) and/ or cardiac resynchronization therapy.
boolean
C0030163 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
C1167956 (UMLS CUI [3])
valvular heart disease
Item
8. clinically relevant valvular heart disease.
boolean
C0018824 (UMLS CUI [1])
coronary artery disease or myocardial infarction
Item
9. coronary artery disease or an old myocardial infarction
boolean
C0010068 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
acute or chronic infection
Item
10. acute or chronic infection.
boolean
C0275518 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
hypothyroidism or hyperthyroidism
Item
11. untreated clinical hypo- or hyperthyroidism or < 3 months euthyroidism.
boolean
C0020676 (UMLS CUI [1])
C0020550 (UMLS CUI [2])
uncontrolled arterial hypertension
Item
12. uncontrolled hypertension, defined as a systolic blood pressure > 160 mm hg and/or a diastolic blood pressure > 95 mm hg (anti-hypertensive treatment is allowed).
boolean
C0020538 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
comorbidity, compliance
Item
13. the patient has a concurrent medical condition (i.e. alcohol or drug abuse or a severe progressive extracardiac disease) or is unlikely to comply with the protocol.
boolean
C0009488 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
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