ID

37495

Beschrijving

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

Trefwoorden

  1. 02-08-19 02-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

2 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT01520532

Eligibility Atrial Fibrillation NCT01520532

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

boolean

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

Atrial Fibrillation

Datatype

boolean

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

Indication Pulmonary vein Ablation | Use of Pulmonary vein Ablation catheter

Datatype

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.
Beschrijving

Informed Consent | Informed Consent Patient Representative

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has permanent af
Beschrijving

Permanent atrial fibrillation

Datatype

boolean

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

Thrombus of left atrium Transesophageal Echocardiography

Datatype

boolean

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

Left atrium Ablation

Datatype

boolean

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

Thrombus of cardiac chamber

Datatype

boolean

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

Medical contraindication Warfarin | Medical contraindication Coumadin

Datatype

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
Beschrijving

Heart Valve Prosthesis

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

Pulmonary vein Stent

Datatype

boolean

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

Pulmonary Vein Stenosis Pre-existing

Datatype

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
Beschrijving

Event Cerebral Ischemic | Cerebrovascular accident | Transient Ischemic Attack

Datatype

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
Beschrijving

Pregnancy

Datatype

boolean

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

Protocol Compliance Unwilling | Protocol Compliance Unable

Datatype

boolean

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

Similar models

Eligibility Atrial Fibrillation NCT01520532

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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