ID

37450

Description

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

Lien

https://clinicaltrials.gov/show/NCT00821015

Mots-clés

  1. 28/07/2019 28/07/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

28 juillet 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT00821015

Eligibility Atrial Fibrillation NCT00821015

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented paroxysmal atrial fibrillation
Description

Paroxysmal atrial fibrillation

Type de données

boolean

Alias
UMLS CUI [1]
C0235480
≥ 18 and ≤ 85 years of age
Description

Age

Type de données

boolean

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

Therapy Atrial Fibrillation | Pharmaceutical Preparations Quantity failed

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

Alias
UMLS CUI [1]
C0023671

Similar models

Eligibility Atrial Fibrillation NCT00821015

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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