ID

25860

Description

PV-Isolation With the Cryoballoon Versus RF:a Randomized Controlled Prospective Non-inferiority Trial (FreezeAF); ODM derived from: https://clinicaltrials.gov/show/NCT00774566

Link

https://clinicaltrials.gov/show/NCT00774566

Keywords

Versions (1)
  1. 9/22/17 9/22/17 -
Uploaded on

September 22, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00774566

English

Eligibility Atrial Fibrillation NCT00774566

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented paroxysmal paf: paf diagnosis, 2 episodes of paf within the last 3 months, at least 1 episode of paf must be documented.
Description

Paroxysmal atrial fibrillation | Paroxysmal atrial fibrillation Episode Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2,1]
C0235480
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C1265611
age 18-75
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
documented effectiveness failure of at least 1 aad including beta-blockers
Description

Effectiveness failed | Anti-Arrhythmia Agents Quantity | Adrenergic beta-Antagonists

Data type

boolean

Alias
UMLS CUI [1,1]
C0087113
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0001645
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
aad usage < 3 half life periods (except beta-blocker)
Description

Anti-Arrhythmia Agents Usage Duration | Exception Adrenergic beta-Antagonists

Data type

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0242510
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0001645
la size > 55 mm
Description

Left atrium cavity size

Data type

boolean

Alias
UMLS CUI [1]
C1302212
la thrombus
Description

Thrombus of left atrium

Data type

boolean

Alias
UMLS CUI [1]
C3532827
previous la ablation/surgery, structural heart disease, heart failure class iii-iv
Description

Left atrium Ablation | Left atrium Operative Surgical Procedures | Structural disorder of heart | Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0547070
UMLS CUI [2,1]
C0225860
UMLS CUI [2,2]
C0543467
UMLS CUI [3]
C1290384
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C1275491
hypertrophic cardiomyopathy
Description

Hypertrophic Cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C0007194
mitral prosthesis
Description

Mitral valve prosthesis

Data type

boolean

Alias
UMLS CUI [1]
C0182494
unstable angina
Description

Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0002965
uncontrolled hyperthyroidism
Description

Hyperthyroidism Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0020550
UMLS CUI [1,2]
C0205318
stroke or tia within 6 months
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
myocardial infarction within 2 months
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
cardiac surgery within 3 months
Description

Cardiac Surgery procedures

Data type

boolean

Alias
UMLS CUI [1]
C0018821
thrombocytosis, thrombocytopenia
Description

Thrombocytosis | Thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1]
C0836924
UMLS CUI [2]
C0040034
any condition contraindicating chronic anticoagulation
Description

Medical contraindication Chronic anticoagulation

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0694554
ef < 40%
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
life expectancy < 1 year
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Atrial Fibrillation NCT00774566

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation | Paroxysmal atrial fibrillation Episode Quantity
Item
documented paroxysmal paf: paf diagnosis, 2 episodes of paf within the last 3 months, at least 1 episode of paf must be documented.
boolean
C0235480 (UMLS CUI [1])
C0235480 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Age
Item
age 18-75
boolean
C0001779 (UMLS CUI [1])
Effectiveness failed | Anti-Arrhythmia Agents Quantity | Adrenergic beta-Antagonists
Item
documented effectiveness failure of at least 1 aad including beta-blockers
boolean
C0087113 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0003195 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0001645 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Anti-Arrhythmia Agents Usage Duration | Exception Adrenergic beta-Antagonists
Item
aad usage < 3 half life periods (except beta-blocker)
boolean
C0003195 (UMLS CUI [1,1])
C0242510 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0001645 (UMLS CUI [2,2])
Left atrium cavity size
Item
la size > 55 mm
boolean
C1302212 (UMLS CUI [1])
Thrombus of left atrium
Item
la thrombus
boolean
C3532827 (UMLS CUI [1])
Left atrium Ablation | Left atrium Operative Surgical Procedures | Structural disorder of heart | Heart failure New York Heart Association Classification
Item
previous la ablation/surgery, structural heart disease, heart failure class iii-iv
boolean
C0225860 (UMLS CUI [1,1])
C0547070 (UMLS CUI [1,2])
C0225860 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C1290384 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
Hypertrophic Cardiomyopathy
Item
hypertrophic cardiomyopathy
boolean
C0007194 (UMLS CUI [1])
Mitral valve prosthesis
Item
mitral prosthesis
boolean
C0182494 (UMLS CUI [1])
Angina, Unstable
Item
unstable angina
boolean
C0002965 (UMLS CUI [1])
Hyperthyroidism Uncontrolled
Item
uncontrolled hyperthyroidism
boolean
C0020550 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Cerebrovascular accident | Transient Ischemic Attack
Item
stroke or tia within 6 months
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Myocardial Infarction
Item
myocardial infarction within 2 months
boolean
C0027051 (UMLS CUI [1])
Cardiac Surgery procedures
Item
cardiac surgery within 3 months
boolean
C0018821 (UMLS CUI [1])
Thrombocytosis | Thrombocytopenia
Item
thrombocytosis, thrombocytopenia
boolean
C0836924 (UMLS CUI [1])
C0040034 (UMLS CUI [2])
Medical contraindication Chronic anticoagulation
Item
any condition contraindicating chronic anticoagulation
boolean
C1301624 (UMLS CUI [1,1])
C0694554 (UMLS CUI [1,2])
Cardiac ejection fraction
Item
ef < 40%
boolean
C0232174 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Life Expectancy
Item
life expectancy < 1 year
boolean
C0023671 (UMLS CUI [1])
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