ID

22398

Description

A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT00523978

Link

https://clinicaltrials.gov/show/NCT00523978

Keywords

Versions (1)
  1. 6/1/17 6/1/17 -
Uploaded on

June 1, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Paroxysmal Atrial Fibrillation NCT00523978

English

Eligibility Paroxysmal Atrial Fibrillation NCT00523978

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Paroxysmal atrial fibrillation | Paroxysmal atrial fibrillation Episode of 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 one (1) af drug
Description

Atrial Fibrillation | Pharmaceutical Preparations Quantity Effectiveness failed

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1280519
UMLS CUI [2,4]
C0231175
willing to be randomized to either group and do full 12 month follow-up
Description

Randomization Group Willing | Clinical Study Follow-up Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0441833
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0600109
able to follow standardized af drug protocol
Description

Atrial Fibrillation | Pharmaceutical Preparations Protocol Adherence

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C1510802
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any cardioversion within 3 months or more than 2 within 2 years
Description

Atrial cardioversion

Data type

boolean

Alias
UMLS CUI [1]
C0199550
amiodarone within 6 months
Description

Amiodarone

Data type

boolean

Alias
UMLS CUI [1]
C0002598
la size > 5.0cm
Description

Left atrium size

Data type

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0456389
previous la ablation/surgery, structural heart disease, heart failure class iii or 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, mitral prosthesis
Description

Hypertrophic Cardiomyopathy | Mitral valve prosthesis

Data type

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2]
C0182494
unstable angina, uncontrolled hyperthyroidism
Description

Angina, Unstable | Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C1868885
stroke or tia within 6 months, mi within 2 months, cardiac surgery within 3 months
Description

Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Cardiac Surgery procedures

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0027051
UMLS CUI [4]
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 <1year
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Paroxysmal Atrial Fibrillation NCT00523978

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation | Paroxysmal atrial fibrillation Episode of Quantity
Item
documented paroxysmal atrial fibrillation (paf): paf diagnosis, 2 episodes of paf within the last 2 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])
Atrial Fibrillation | Pharmaceutical Preparations Quantity Effectiveness failed
Item
documented effectiveness failure of one (1) af drug
boolean
C0004238 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1280519 (UMLS CUI [2,3])
C0231175 (UMLS CUI [2,4])
Randomization Group Willing | Clinical Study Follow-up Willing
Item
willing to be randomized to either group and do full 12 month follow-up
boolean
C0034656 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C3274571 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Atrial Fibrillation | Pharmaceutical Preparations Protocol Adherence
Item
able to follow standardized af drug protocol
boolean
C0004238 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C1510802 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Atrial cardioversion
Item
any cardioversion within 3 months or more than 2 within 2 years
boolean
C0199550 (UMLS CUI [1])
Amiodarone
Item
amiodarone within 6 months
boolean
C0002598 (UMLS CUI [1])
Left atrium size
Item
la size > 5.0cm
boolean
C0225860 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
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 or 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 | Mitral valve prosthesis
Item
hypertrophic cardiomyopathy, mitral prosthesis
boolean
C0007194 (UMLS CUI [1])
C0182494 (UMLS CUI [2])
Angina, Unstable | Uncontrolled hypertension
Item
unstable angina, uncontrolled hyperthyroidism
boolean
C0002965 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Cardiac Surgery procedures
Item
stroke or tia within 6 months, mi within 2 months, cardiac surgery within 3 months
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0018821 (UMLS CUI [4])
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 <1year
boolean
C0023671 (UMLS CUI [1])
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