ID

20987

Description

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

Lien

https://clinicaltrials.gov/show/NCT00448656

Mots-clés

Versions (1)
  1. 02/04/2017 02/04/2017 -
Téléchargé le

2 avril 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00448656

Anglais

Eligibility Atrial Fibrillation NCT00448656

1 Formulaires  
Inclusion Criteria
Description

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.
Description

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

Type de données

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.
Description

persistent or paroxysmal atrial fibrillation

Type de données

boolean

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

persistent atrial fibrillation duration

Type de données

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.
Description

treatment with antiarrhythmic drug

Type de données

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.
Description

informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

ID.6

Type de données

boolean

2. contraindications for oral anticoagulation.
Description

oral anticoagulation contraindication

Type de données

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).
Description

signs of sick sinus syndrome or av conduction disturbance

Type de données

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.
Description

permanent atrial fibrillation not convertible

Type de données

boolean

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

transvenous pulmonary veis isolation, maze surgery or other cardiac surgery

Type de données

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.
Description

heart failure nyha iii-iv

Type de données

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.
Description

implanted intracardiac device

Type de données

boolean

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

valvular heart disease

Type de données

boolean

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

coronary artery disease or myocardial infarction

Type de données

boolean

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

acute or chronic infection

Type de données

boolean

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

hypothyroidism or hyperthyroidism

Type de données

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).
Description

uncontrolled arterial hypertension

Type de données

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.
Description

comorbidity, compliance

Type de données

boolean

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

Eligibility Atrial Fibrillation NCT00448656

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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