ID

18703

Beschrijving

A Trial of Circumferential Pulmonary Vein Ablation (CPVA) Versus Antiarrhythmic Drug Therapy in for Paroxysmal Atrial Fibrillation (AF); ODM derived from: https://clinicaltrials.gov/show/NCT00340314

Link

https://clinicaltrials.gov/show/NCT00340314

Trefwoorden

Versies (1)
  1. 17-11-16 17-11-16 -
Geüploaded op

17 november 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00340314

Engels

Eligibility Atrial Fibrillation NCT00340314

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18-70 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. history of symptomatic paroxysmal af lasting more than 6 months. paroxysms of af are intended as recurrent self-terminating episodes lasting less than 7 days and occurring more than 2 times every month.
Beschrijving

Symptomatic paroxysmal atrial fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C0235480
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnancy
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
2. nyha functional class iii or iv
Beschrijving

NYHA

Datatype

boolean

Alias
UMLS CUI [1]
C1275491
3. left atrial size > 65 mm
Beschrijving

left atrial size

Datatype

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0456389
4. left ventricular (lv) ejection fraction < 35%
Beschrijving

LVEF

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
5. contraindication to anticoagulation with warfarin
Beschrijving

contraindication to anticoagulation with warfarin

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0043031
6. history of myocardial infarction within six months of the procedure
Beschrijving

myocardial infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
7. prior catheter or surgical ablation attempt for af
Beschrijving

Catheter or surgical ablation attempt for af

Datatype

boolean

Alias
UMLS CUI [1]
C2702800
UMLS CUI [2]
C3520506
8. inability or unwillingness to provide written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
9. life expectancy less than 1 year
Beschrijving

life expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
10. significant comorbid conditions such as: cancer (not cured), end stage renal disease (creatinine clearance < 20 ml/h), severe chronic obstructive lung disease, cirrhosis, etc)
Beschrijving

Significant comorbid conditions such as: cancer, end stage renal disease, severe chronic obstructive lung disease, cirrhosis

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0373595
UMLS CUI [4]
C0024117
UMLS CUI [5]
C0023890
11. anticipated cardiac surgery for congenital, valvular, aortic or coronary heart disease.
Beschrijving

anticipated cardiac surgery for congenital, valvular, aortic or coronary heart disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C0152021
UMLS CUI [2,1]
C0018821
UMLS CUI [2,2]
C0018824
UMLS CUI [3,1]
C0018821
UMLS CUI [3,2]
C0003493
UMLS CUI [4,1]
C0018821
UMLS CUI [4,2]
C0010068
12. presence of left atrial thrombus.
Beschrijving

left atrial thrombus

Datatype

boolean

Alias
UMLS CUI [1]
C3532827
13. prior antiarrhythmic drug therapy with amiodarone, sotalol and flecainide at optimal doses (target 200 mg, 240 mg, 200 mg daily respectively
Beschrijving

antiarrhythmic drug therapy with amiodarone, sotalol and flecainide

Datatype

boolean

Alias
UMLS CUI [1]
C0002598
UMLS CUI [2]
C0037707
UMLS CUI [3]
C0016229
14. af burden < 2 episodes/month
Beschrijving

Atrial fibrillation burden

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C4086638
15. wpw
Beschrijving

WPW Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0043202
16. expected survival < 1 year
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
17. contraindications for antiarrhythmics therapy including flecainide, sotalol or amiodarone not listed above:
Beschrijving

contraindications for antiarrhythmics therapy including flecainide, sotalol or amiodarone

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003195
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0002598
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0037707
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0016229
lv hypertrophy (lv mass index > 125g/m2)
Beschrijving

Left ventricular hypertrophy

Datatype

boolean

Alias
UMLS CUI [1]
C0149721
thyroid dysfunction (hyperthyroidism or uncontrolled hypothyroidism or thyroid cancer)
Beschrijving

thyroid dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C0348024
liver dysfunction (alt or ast >2x the reference values)
Beschrijving

ALT, AST

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
interstitial lung disease with dlco<70% of predicted or severe asthma.
Beschrijving

interstitial lung disease with dlco<70% of predicted or severe asthma

Datatype

boolean

Alias
UMLS CUI [1]
C1869044
UMLS CUI [2]
C1516251
UMLS CUI [3]
C0004096
qt interval exceeding 400 msec
Beschrijving

QT interval

Datatype

boolean

Alias
UMLS CUI [1]
C0429028
symptomatic sinus node or atrioventricular node dysfunction unless a pacemaker had been implanted
Beschrijving

Sinus Node or AV Node Dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C0428908
UMLS CUI [2]
C0741301
evidence of stress-induced myocardial ischemia
Beschrijving

Myocardial ischemia

Datatype

boolean

Alias
UMLS CUI [1]
C0151744
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Similar models

Eligibility Atrial Fibrillation NCT00340314

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18-70 years
boolean
C0001779 (UMLS CUI [1])
Symptomatic paroxysmal atrial fibrillation
Item
2. history of symptomatic paroxysmal af lasting more than 6 months. paroxysms of af are intended as recurrent self-terminating episodes lasting less than 7 days and occurring more than 2 times every month.
boolean
C0235480 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
1. pregnancy
boolean
C0032961 (UMLS CUI [1])
NYHA
Item
2. nyha functional class iii or iv
boolean
C1275491 (UMLS CUI [1])
left atrial size
Item
3. left atrial size > 65 mm
boolean
C0225860 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
LVEF
Item
4. left ventricular (lv) ejection fraction < 35%
boolean
C0428772 (UMLS CUI [1])
contraindication to anticoagulation with warfarin
Item
5. contraindication to anticoagulation with warfarin
boolean
C1301624 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
myocardial infarction
Item
6. history of myocardial infarction within six months of the procedure
boolean
C0027051 (UMLS CUI [1])
Catheter or surgical ablation attempt for af
Item
7. prior catheter or surgical ablation attempt for af
boolean
C2702800 (UMLS CUI [1])
C3520506 (UMLS CUI [2])
Informed Consent
Item
8. inability or unwillingness to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
life expectancy
Item
9. life expectancy less than 1 year
boolean
C0023671 (UMLS CUI [1])
Significant comorbid conditions such as: cancer, end stage renal disease, severe chronic obstructive lung disease, cirrhosis
Item
10. significant comorbid conditions such as: cancer (not cured), end stage renal disease (creatinine clearance < 20 ml/h), severe chronic obstructive lung disease, cirrhosis, etc)
boolean
C0009488 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C0024117 (UMLS CUI [4])
C0023890 (UMLS CUI [5])
anticipated cardiac surgery for congenital, valvular, aortic or coronary heart disease
Item
11. anticipated cardiac surgery for congenital, valvular, aortic or coronary heart disease.
boolean
C0018821 (UMLS CUI [1,1])
C0152021 (UMLS CUI [1,2])
C0018821 (UMLS CUI [2,1])
C0018824 (UMLS CUI [2,2])
C0018821 (UMLS CUI [3,1])
C0003493 (UMLS CUI [3,2])
C0018821 (UMLS CUI [4,1])
C0010068 (UMLS CUI [4,2])
left atrial thrombus
Item
12. presence of left atrial thrombus.
boolean
C3532827 (UMLS CUI [1])
antiarrhythmic drug therapy with amiodarone, sotalol and flecainide
Item
13. prior antiarrhythmic drug therapy with amiodarone, sotalol and flecainide at optimal doses (target 200 mg, 240 mg, 200 mg daily respectively
boolean
C0002598 (UMLS CUI [1])
C0037707 (UMLS CUI [2])
C0016229 (UMLS CUI [3])
Atrial fibrillation burden
Item
14. af burden < 2 episodes/month
boolean
C0004238 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
WPW Syndrome
Item
15. wpw
boolean
C0043202 (UMLS CUI [1])
Life Expectancy
Item
16. expected survival < 1 year
boolean
C0023671 (UMLS CUI [1])
contraindications for antiarrhythmics therapy including flecainide, sotalol or amiodarone
Item
17. contraindications for antiarrhythmics therapy including flecainide, sotalol or amiodarone not listed above:
boolean
C1301624 (UMLS CUI [1,1])
C0003195 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0002598 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0037707 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0016229 (UMLS CUI [4,2])
Left ventricular hypertrophy
Item
lv hypertrophy (lv mass index > 125g/m2)
boolean
C0149721 (UMLS CUI [1])
thyroid dysfunction
Item
thyroid dysfunction (hyperthyroidism or uncontrolled hypothyroidism or thyroid cancer)
boolean
C0348024 (UMLS CUI [1])
ALT, AST
Item
liver dysfunction (alt or ast >2x the reference values)
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
interstitial lung disease with dlco<70% of predicted or severe asthma
Item
interstitial lung disease with dlco<70% of predicted or severe asthma.
boolean
C1869044 (UMLS CUI [1])
C1516251 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
QT interval
Item
qt interval exceeding 400 msec
boolean
C0429028 (UMLS CUI [1])
Sinus Node or AV Node Dysfunction
Item
symptomatic sinus node or atrioventricular node dysfunction unless a pacemaker had been implanted
boolean
C0428908 (UMLS CUI [1])
C0741301 (UMLS CUI [2])
Myocardial ischemia
Item
evidence of stress-induced myocardial ischemia
boolean
C0151744 (UMLS CUI [1])
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