ID

37450

Description

Effect of Balloon Cryoablation on Left Atrial Function; ODM derived from: https://clinicaltrials.gov/show/NCT00821015

Link

https://clinicaltrials.gov/show/NCT00821015

Keywords

Versions (1)
  1. 7/28/19 7/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 28, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00821015

English

Eligibility Atrial Fibrillation NCT00821015

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 ≤ 85 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
failure of one or more af drugs (afds).
Description

Therapy Atrial Fibrillation | Pharmaceutical Preparations Quantity failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004238
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
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
ability to understand the requirements of the study
Description

Comprehension Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any reversible cause of af (post-surgery, thyroid disorder, etc.)
Description

Cause Reversible Atrial Fibrillation | Status post Operative Surgical Procedure | Thyroid Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0004238
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0543467
UMLS CUI [3]
C0040128
more than 4 cardioversions in the prior year.
Description

Electric Countershock Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0013778
UMLS CUI [1,2]
C1265611
patients with recent myocardial infarction (less than 2 months) or unstable angina.
Description

Myocardial Infarction | Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
patients with congestive heart failure (nyha class iii or iv).
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
patients who have experienced any cerebral ischemic event, including any tia in the preceding 1 month.
Description

Cerebral Ischemia | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0917798
UMLS CUI [2]
C0007787
women who are known to be pregnant or have had a positive β-hcg test 7 days prior to procedure.
Description

Pregnancy | Serum pregnancy test (B-HCG) Positive

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0430060
UMLS CUI [2,2]
C1514241
patients with any other significant uncontrolled or unstable medical condition (including uncontrolled clinically significant coagulation disorders).
Description

Other medical condition Uncontrolled | Other medical condition Unstable | Blood Coagulation Disorders Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0005779
UMLS CUI [3,2]
C0205318
patients whose life expectancy is less than one year.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Atrial Fibrillation NCT00821015

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 ≤ 85 years of age
boolean
C0001779 (UMLS CUI [1])
Therapy Atrial Fibrillation | Pharmaceutical Preparations Quantity failed
Item
failure of one or more af drugs (afds).
boolean
C0087111 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
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])
Comprehension Study Protocol
Item
ability to understand the requirements of the study
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Protocol Compliance
Item
willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cause Reversible Atrial Fibrillation | Status post Operative Surgical Procedure | Thyroid Disease
Item
any reversible cause of af (post-surgery, thyroid disorder, etc.)
boolean
C0015127 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0040128 (UMLS CUI [3])
Electric Countershock Quantity
Item
more than 4 cardioversions in the prior year.
boolean
C0013778 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Myocardial Infarction | Angina, Unstable
Item
patients with recent myocardial infarction (less than 2 months) or unstable angina.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification
Item
patients with congestive heart failure (nyha class iii or iv).
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cerebral Ischemia | Transient Ischemic Attack
Item
patients who have experienced any cerebral ischemic event, including any tia in the preceding 1 month.
boolean
C0917798 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Pregnancy | Serum pregnancy test (B-HCG) Positive
Item
women who are known to be pregnant or have had a positive β-hcg test 7 days prior to procedure.
boolean
C0032961 (UMLS CUI [1])
C0430060 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Other medical condition Uncontrolled | Other medical condition Unstable | Blood Coagulation Disorders Uncontrolled
Item
patients with any other significant uncontrolled or unstable medical condition (including uncontrolled clinically significant coagulation disorders).
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0005779 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Life Expectancy
Item
patients whose life expectancy is less than one year.
boolean
C0023671 (UMLS CUI [1])
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