ID

37495

Descripción

Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC); ODM derived from: https://clinicaltrials.gov/show/NCT01520532

Link

https://clinicaltrials.gov/show/NCT01520532

Palabras clave

Versiones (1)
  1. 2/8/19 2/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de agosto de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01520532

Inglés

Eligibility Atrial Fibrillation NCT01520532

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is at least 18 years old
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
subject has been diagnosed with atrial fibrillation (af)
Descripción

Atrial Fibrillation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004238
subject is indicated for a pulmonary vein ablation using pvac
Descripción

Indication Pulmonary vein Ablation | Use of Pulmonary vein Ablation catheter

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0034090
UMLS CUI [1,3]
C0547070
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0034090
UMLS CUI [2,3]
C0877859
subject (or subject's legally authorized representative) is able and and willing to give informed consent.
Descripción

Informed Consent | Informed Consent Patient Representative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has permanent af
Descripción

Permanent atrial fibrillation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2586056
subject has a left atrial thrombus detected on tee
Descripción

Thrombus of left atrium Transesophageal Echocardiography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3532827
UMLS CUI [1,2]
C0206054
subject has had a prior left atrial ablation
Descripción

Left atrium Ablation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0547070
subject has a intracardiac thrombus
Descripción

Thrombus of cardiac chamber

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0876998
subject is contraindicated for warfarin (coumadin)
Descripción

Medical contraindication Warfarin | Medical contraindication Coumadin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0043031
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0699129
subject has a cardiac valve prosthesis
Descripción

Heart Valve Prosthesis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018825
subject has a significant congenital heart defect corrected or not including atrial septal defects or pulmonary vein abnormalities but not including minor pfo)
Descripción

Congenital Heart Defects Corrected | Congenital Heart Defects | Atrial Septal Defects | Anomalous pulmonary vein | Exception PFO Minor

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018798
UMLS CUI [1,2]
C0205202
UMLS CUI [2]
C0018798
UMLS CUI [3]
C0018817
UMLS CUI [4]
C0265914
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0016522
UMLS CUI [5,3]
C0205165
subject has presence of any pulmonary vein stents
Descripción

Pulmonary vein Stent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0034090
UMLS CUI [1,2]
C0038257
subject has presence of any pre-existing pulmonary vein stenosis
Descripción

Pulmonary Vein Stenosis Pre-existing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0340756
UMLS CUI [1,2]
C2347662
subject has had a cerebral ischemic event (strokes or transient ischemic attacks [tia]) which occurred during the 6 month interval preceding the consent date
Descripción

Event Cerebral Ischemic | Cerebrovascular accident | Transient Ischemic Attack

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0006104
UMLS CUI [1,3]
C0475224
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
subject is a woman known to be pregnant
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
subject is unwilling or unable to comply fully with study procedures and follow-up
Descripción

Protocol Compliance Unwilling | Protocol Compliance Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Atrial Fibrillation NCT01520532

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subject is at least 18 years old
boolean
C0001779 (UMLS CUI [1])
Atrial Fibrillation
Item
subject has been diagnosed with atrial fibrillation (af)
boolean
C0004238 (UMLS CUI [1])
Indication Pulmonary vein Ablation | Use of Pulmonary vein Ablation catheter
Item
subject is indicated for a pulmonary vein ablation using pvac
boolean
C3146298 (UMLS CUI [1,1])
C0034090 (UMLS CUI [1,2])
C0547070 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C0034090 (UMLS CUI [2,2])
C0877859 (UMLS CUI [2,3])
Informed Consent | Informed Consent Patient Representative
Item
subject (or subject's legally authorized representative) is able and and willing to give informed consent.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Permanent atrial fibrillation
Item
subject has permanent af
boolean
C2586056 (UMLS CUI [1])
Thrombus of left atrium Transesophageal Echocardiography
Item
subject has a left atrial thrombus detected on tee
boolean
C3532827 (UMLS CUI [1,1])
C0206054 (UMLS CUI [1,2])
Left atrium Ablation
Item
subject has had a prior left atrial ablation
boolean
C0225860 (UMLS CUI [1,1])
C0547070 (UMLS CUI [1,2])
Thrombus of cardiac chamber
Item
subject has a intracardiac thrombus
boolean
C0876998 (UMLS CUI [1])
Medical contraindication Warfarin | Medical contraindication Coumadin
Item
subject is contraindicated for warfarin (coumadin)
boolean
C1301624 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0699129 (UMLS CUI [2,2])
Heart Valve Prosthesis
Item
subject has a cardiac valve prosthesis
boolean
C0018825 (UMLS CUI [1])
Congenital Heart Defects Corrected | Congenital Heart Defects | Atrial Septal Defects | Anomalous pulmonary vein | Exception PFO Minor
Item
subject has a significant congenital heart defect corrected or not including atrial septal defects or pulmonary vein abnormalities but not including minor pfo)
boolean
C0018798 (UMLS CUI [1,1])
C0205202 (UMLS CUI [1,2])
C0018798 (UMLS CUI [2])
C0018817 (UMLS CUI [3])
C0265914 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0016522 (UMLS CUI [5,2])
C0205165 (UMLS CUI [5,3])
Pulmonary vein Stent
Item
subject has presence of any pulmonary vein stents
boolean
C0034090 (UMLS CUI [1,1])
C0038257 (UMLS CUI [1,2])
Pulmonary Vein Stenosis Pre-existing
Item
subject has presence of any pre-existing pulmonary vein stenosis
boolean
C0340756 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Event Cerebral Ischemic | Cerebrovascular accident | Transient Ischemic Attack
Item
subject has had a cerebral ischemic event (strokes or transient ischemic attacks [tia]) which occurred during the 6 month interval preceding the consent date
boolean
C0441471 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
C0475224 (UMLS CUI [1,3])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Pregnancy
Item
subject is a woman known to be pregnant
boolean
C0032961 (UMLS CUI [1])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
subject is unwilling or unable to comply fully with study procedures and follow-up
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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