ID

37488

Description

Kansai Plus Atrial Fibrillation Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01477983

Link

https://clinicaltrials.gov/show/NCT01477983

Keywords

Versions (1)
  1. 8/2/19 8/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01477983

English

Eligibility Atrial Fibrillation NCT01477983

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients undergoing first catheter ablation including pv isolation for paroxysmal or persistent atrial fibrillation
Description

Catheter ablation First Pulmonary vein isolation Paroxysmal atrial fibrillation | Catheter ablation First Pulmonary vein isolation Persistent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1,1]
C2702799
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C3544330
UMLS CUI [1,4]
C0235480
UMLS CUI [2,1]
C2702799
UMLS CUI [2,2]
C0205435
UMLS CUI [2,3]
C3544330
UMLS CUI [2,4]
C2585653
patients who are 21-79 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
able to be followed for one year in an out-patient clinic
Description

Follow-up Able Outpatient clinic

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0085732
UMLS CUI [1,3]
C0002424
willing to sign the consent form for participation
Description

Informed Consent Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindication or intolerance to adenosine triphosphate or vaughan williams class i or iii antiarrhythmic drugs, including severe bronchial asthma, severe vasospastic angina, and substantial bradycardia including sinus node dysfunction with prolonged pauses on termination of atrial fibrillation
Description

Medical contraindication Adenosine Triphosphate | Intolerance to Adenosine Triphosphate | Medical contraindication Anti-Arrhythmia Agents Class | Intolerance to Anti-Arrhythmia Agents Class | Severe asthma | Vasospastic Angina Severe | Bradycardia Essential | Sinus Node Dysfunction

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001480
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0001480
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0003195
UMLS CUI [3,3]
C0456387
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0003195
UMLS CUI [4,3]
C0456387
UMLS CUI [5]
C0581126
UMLS CUI [6,1]
C0002963
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0428977
UMLS CUI [7,2]
C0205224
UMLS CUI [8]
C0428908
age =< 20 years or => 80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
renal insufficiency (serum creatinine >=2.0mg/dl or hemodialysis)
Description

Renal Insufficiency | Creatinine measurement, serum | Hemodialysis

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0019004
nyha class iv heart failure
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
left ventricular ejection fraction < 40%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
left atrial diameter > 55mm
Description

Left atrium Diameter Size

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0456389
very long-lasting (>=5years) persistent atrial fibrillation
Description

Very longstanding persistent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1,1]
C3873617
UMLS CUI [1,2]
C0442824
ineligible for optimal anticoagulant therapy
Description

Ineligibility Anticoagulant therapy Optimal

Data type

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0150457
UMLS CUI [1,3]
C2698651
history of myocardial infarction within the past 6 months
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
prior or planned open heart surgery
Description

Open heart surgery | Open heart surgery Planned

Data type

boolean

Alias
UMLS CUI [1]
C0189745
UMLS CUI [2,1]
C0189745
UMLS CUI [2,2]
C1301732
severe valve heart disease
Description

Heart valve disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205082
unable to be followed in an out-patient clinic for one year
Description

Follow-up Unable Outpatient clinic

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0002424
unwilling to sign the consent form for participation
Description

Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
when the attending physician are unwilling to enroll the patient in the study
Description

Attending physician Unwilling Patient Enrollment

Data type

boolean

Alias
UMLS CUI [1,1]
C1320929
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C0030705
UMLS CUI [1,4]
C1516879
when the attending physician consider inappropriate to enroll the patient in the study
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
those with severe procedural complications (east-af trial only)
Description

Procedural complication Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C1141861
UMLS CUI [1,2]
C0205082
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Similar models

Eligibility Atrial Fibrillation NCT01477983

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Catheter ablation First Pulmonary vein isolation Paroxysmal atrial fibrillation | Catheter ablation First Pulmonary vein isolation Persistent atrial fibrillation
Item
patients undergoing first catheter ablation including pv isolation for paroxysmal or persistent atrial fibrillation
boolean
C2702799 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C3544330 (UMLS CUI [1,3])
C0235480 (UMLS CUI [1,4])
C2702799 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
C3544330 (UMLS CUI [2,3])
C2585653 (UMLS CUI [2,4])
Age
Item
patients who are 21-79 years old
boolean
C0001779 (UMLS CUI [1])
Follow-up Able Outpatient clinic
Item
able to be followed for one year in an out-patient clinic
boolean
C3274571 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0002424 (UMLS CUI [1,3])
Informed Consent Willing
Item
willing to sign the consent form for participation
boolean
C0021430 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Adenosine Triphosphate | Intolerance to Adenosine Triphosphate | Medical contraindication Anti-Arrhythmia Agents Class | Intolerance to Anti-Arrhythmia Agents Class | Severe asthma | Vasospastic Angina Severe | Bradycardia Essential | Sinus Node Dysfunction
Item
contraindication or intolerance to adenosine triphosphate or vaughan williams class i or iii antiarrhythmic drugs, including severe bronchial asthma, severe vasospastic angina, and substantial bradycardia including sinus node dysfunction with prolonged pauses on termination of atrial fibrillation
boolean
C1301624 (UMLS CUI [1,1])
C0001480 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0001480 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0003195 (UMLS CUI [3,2])
C0456387 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C0003195 (UMLS CUI [4,2])
C0456387 (UMLS CUI [4,3])
C0581126 (UMLS CUI [5])
C0002963 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0428977 (UMLS CUI [7,1])
C0205224 (UMLS CUI [7,2])
C0428908 (UMLS CUI [8])
Age
Item
age =< 20 years or => 80 years
boolean
C0001779 (UMLS CUI [1])
Renal Insufficiency | Creatinine measurement, serum | Hemodialysis
Item
renal insufficiency (serum creatinine >=2.0mg/dl or hemodialysis)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0019004 (UMLS CUI [3])
Heart failure New York Heart Association Classification
Item
nyha class iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction < 40%
boolean
C0428772 (UMLS CUI [1])
Left atrium Diameter Size
Item
left atrial diameter > 55mm
boolean
C0225860 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Very longstanding persistent atrial fibrillation
Item
very long-lasting (>=5years) persistent atrial fibrillation
boolean
C3873617 (UMLS CUI [1,1])
C0442824 (UMLS CUI [1,2])
Ineligibility Anticoagulant therapy Optimal
Item
ineligible for optimal anticoagulant therapy
boolean
C1512714 (UMLS CUI [1,1])
C0150457 (UMLS CUI [1,2])
C2698651 (UMLS CUI [1,3])
Myocardial Infarction
Item
history of myocardial infarction within the past 6 months
boolean
C0027051 (UMLS CUI [1])
Open heart surgery | Open heart surgery Planned
Item
prior or planned open heart surgery
boolean
C0189745 (UMLS CUI [1])
C0189745 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Heart valve disease Severe
Item
severe valve heart disease
boolean
C0018824 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Follow-up Unable Outpatient clinic
Item
unable to be followed in an out-patient clinic for one year
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0002424 (UMLS CUI [1,3])
Informed Consent Unwilling
Item
unwilling to sign the consent form for participation
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Attending physician Unwilling Patient Enrollment
Item
when the attending physician are unwilling to enroll the patient in the study
boolean
C1320929 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C1516879 (UMLS CUI [1,4])
Study Subject Participation Status Inappropriate
Item
when the attending physician consider inappropriate to enroll the patient in the study
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
Procedural complication Severe
Item
those with severe procedural complications (east-af trial only)
boolean
C1141861 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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