ID

34142

Description

Colibri Foresight ICE System; ODM derived from: https://clinicaltrials.gov/show/NCT02514876

Link

https://clinicaltrials.gov/show/NCT02514876

Keywords

  1. 1/14/19 1/14/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 14, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Atrial Fibrillation NCT02514876

Eligibility Atrial Fibrillation NCT02514876

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is at least 18 years old.
Description

ID.1

Data type

boolean

patient is undergoing an atrial fibrillation ablation procedure.
Description

ID.2

Data type

boolean

patient has a transesophageal echocardiogram (tee) within the 48 hours prior to ablation procedure to rule out left atrial thrombus.
Description

ID.3

Data type

boolean

patient provides informed, written consent for participation in the study.
Description

ID.4

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients in whom placement of an ice catheter in the right atrium for adequate atrial visualization is not technically feasible (as evaluated and determined by the physician performing the procedure).
Description

ID.5

Data type

boolean

patients in whom transseptal puncture is relatively contraindicated.
Description

ID.6

Data type

boolean

patients in whom left atrial clot or dense spontaneous contrast is identified on tee, which would increase thromboembolic risk.
Description

ID.7

Data type

boolean

women of child bearing potential, in whom pregnancy cannot be excluded.
Description

ID.8

Data type

boolean

patients unable to grant informed, written consent for participation in the study.
Description

ID.9

Data type

boolean

Similar models

Eligibility Atrial Fibrillation NCT02514876

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
patient is at least 18 years old.
boolean
ID.2
Item
patient is undergoing an atrial fibrillation ablation procedure.
boolean
ID.3
Item
patient has a transesophageal echocardiogram (tee) within the 48 hours prior to ablation procedure to rule out left atrial thrombus.
boolean
ID.4
Item
patient provides informed, written consent for participation in the study.
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
patients in whom placement of an ice catheter in the right atrium for adequate atrial visualization is not technically feasible (as evaluated and determined by the physician performing the procedure).
boolean
ID.6
Item
patients in whom transseptal puncture is relatively contraindicated.
boolean
ID.7
Item
patients in whom left atrial clot or dense spontaneous contrast is identified on tee, which would increase thromboembolic risk.
boolean
ID.8
Item
women of child bearing potential, in whom pregnancy cannot be excluded.
boolean
ID.9
Item
patients unable to grant informed, written consent for participation in the study.
boolean

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