ID

37486

Description

Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter; ODM derived from: https://clinicaltrials.gov/show/NCT01448265

Link

https://clinicaltrials.gov/show/NCT01448265

Keywords

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

See clinicaltrials.gov

Uploaded on

August 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01448265

English

Eligibility Atrial Fibrillation NCT01448265

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented paroxysmal atrial fibrillation
Description

Paroxysmal atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0235480
≥18 and ≤75 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
failure of one or more antiarrhythmic drugs
Description

Anti-Arrhythmia Agents Quantity failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
referral for a pulmonary vein isolation catheter ablation procedure to treat atrial fibrillation
Description

Referral for Pulmonary vein isolation Catheter ablation for atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1,1]
C2585524
UMLS CUI [1,2]
C3544330
UMLS CUI [1,3]
C2702800
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous ablation of atrial fibrillation
Description

Catheter ablation for atrial fibrillation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0205156
documented left atrial thrombus
Description

Thrombus of left atrium

Data type

boolean

Alias
UMLS CUI [1]
C3532827
irregular pulmonary vein anatomy according to transesophageal echocardiography
Description

Pulmonary vein Anatomy Irregular Transesophageal Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0034090
UMLS CUI [1,2]
C0700276
UMLS CUI [1,3]
C0205271
UMLS CUI [1,4]
C0206054
atrial fibrillation secondary to reversible cause
Description

Atrial Fibrillation Secondary to Cause Reversible

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0205343
amiodarone therapy in the previous 6 months
Description

Amiodarone therapy

Data type

boolean

Alias
UMLS CUI [1]
C4303555
cardiac surgery within the prior 6 months
Description

Cardiac Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0018821
myocardial infarction within the previous 2 months
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
ejection fraction < 40%
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
nyha class iii or iv
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
moderate to severe valvular heart disease
Description

Heart valve disease Moderate | Heart valve disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0018824
UMLS CUI [2,2]
C0205082
previous valve replacement
Description

Valve replacement Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1410969
UMLS CUI [1,2]
C0205156
pacemaker or implantable cardioverter defibrillator placement in the prior 3 months
Description

Pacemaker placement | Implantable Cardioverter-Defibrillator Placement

Data type

boolean

Alias
UMLS CUI [1]
C0747130
UMLS CUI [2]
C2825184
history of stroke or tia within the previous 12 months
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
left atrial size ≥ 50 mm
Description

Left atrium Size

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0456389
contraindication for anticoagulation medication
Description

Medical contraindication Anticoagulants

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003280
life expectancy of less than 12 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Atrial Fibrillation NCT01448265

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation
Item
documented paroxysmal atrial fibrillation
boolean
C0235480 (UMLS CUI [1])
Age
Item
≥18 and ≤75 years of age
boolean
C0001779 (UMLS CUI [1])
Anti-Arrhythmia Agents Quantity failed
Item
failure of one or more antiarrhythmic drugs
boolean
C0003195 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Referral for Pulmonary vein isolation Catheter ablation for atrial fibrillation
Item
referral for a pulmonary vein isolation catheter ablation procedure to treat atrial fibrillation
boolean
C2585524 (UMLS CUI [1,1])
C3544330 (UMLS CUI [1,2])
C2702800 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Catheter ablation for atrial fibrillation Previous
Item
previous ablation of atrial fibrillation
boolean
C2702800 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Thrombus of left atrium
Item
documented left atrial thrombus
boolean
C3532827 (UMLS CUI [1])
Pulmonary vein Anatomy Irregular Transesophageal Echocardiography
Item
irregular pulmonary vein anatomy according to transesophageal echocardiography
boolean
C0034090 (UMLS CUI [1,1])
C0700276 (UMLS CUI [1,2])
C0205271 (UMLS CUI [1,3])
C0206054 (UMLS CUI [1,4])
Atrial Fibrillation Secondary to Cause Reversible
Item
atrial fibrillation secondary to reversible cause
boolean
C0004238 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205343 (UMLS CUI [1,4])
Amiodarone therapy
Item
amiodarone therapy in the previous 6 months
boolean
C4303555 (UMLS CUI [1])
Cardiac Surgery
Item
cardiac surgery within the prior 6 months
boolean
C0018821 (UMLS CUI [1])
Myocardial Infarction
Item
myocardial infarction within the previous 2 months
boolean
C0027051 (UMLS CUI [1])
Cardiac ejection fraction
Item
ejection fraction < 40%
boolean
C0232174 (UMLS CUI [1])
New York Heart Association Classification
Item
nyha class iii or iv
boolean
C1275491 (UMLS CUI [1])
Heart valve disease Moderate | Heart valve disease Severe
Item
moderate to severe valvular heart disease
boolean
C0018824 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0018824 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Valve replacement Previous
Item
previous valve replacement
boolean
C1410969 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Pacemaker placement | Implantable Cardioverter-Defibrillator Placement
Item
pacemaker or implantable cardioverter defibrillator placement in the prior 3 months
boolean
C0747130 (UMLS CUI [1])
C2825184 (UMLS CUI [2])
Cerebrovascular accident | Transient Ischemic Attack
Item
history of stroke or tia within the previous 12 months
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Left atrium Size
Item
left atrial size ≥ 50 mm
boolean
C0225860 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Medical contraindication Anticoagulants
Item
contraindication for anticoagulation medication
boolean
C1301624 (UMLS CUI [1,1])
C0003280 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy of less than 12 months
boolean
C0023671 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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