ID

13324

Description

Use of the Self-Expanding CoreValve Prosthesis without Predilation in Patients with Significantly IMPaired Left-VentrIcular Ejection Fraction for Transcatheter Aortic Valve Implantation Study. Form is used in following visits: - Visit 4 (7 days +1d) - Visit 5 (30 days +15d) - Visit 6 (180 day +-30d) - Visit 7 (1 year +1m) Projektleiter (LKP): Prof. Dr. med. Georg Nickenig Medizinische Klinik und Poliklinik II Sigmund-Freud-Str. 25, 53125 Bonn Tel. 0228-287-15217, Fax 0228-287-16423 Email: georg.nickenig@ukb.uni-bonn.de

Keywords

Versions (1)
  1. 2/4/16 2/4/16 -
Uploaded on

February 4, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Endpoints SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746

English

Endpoints NCT01539746

1 forms  
  1. StudyEvent: ODM
    1. Endpoints NCT01539746
Date of visit
Description

Date of visit

Alias
UMLS CUI-1
C1320303
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Endpoints
Description

Endpoints

Alias
UMLS CUI-1
C2347784
Death
Description

Death

Data type

integer

Alias
UMLS CUI [1]
C0011065
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C1148348
Myocardial infarction
Description

Myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0011008
TIA
Description

TIA

Data type

boolean

Alias
UMLS CUI [1]
C0007787
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0007787
Acute kidney failure
Description

Acute kidney failure

Data type

boolean

Alias
UMLS CUI [1]
C0022660
Grading
Description

Grading

Data type

integer

Alias
UMLS CUI [1,1]
C0022660
UMLS CUI [1,2]
C0441799
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0022660
UMLS CUI [1,2]
C0011008
Implantation of pacemaker (or if already implanted pacemaker - ventricular pacing < 10%)
Description

Implantation of pacemaker (or if already implanted pacemaker - ventricular pacing < 10%)

Data type

boolean

Alias
UMLS CUI [1]
C0189842
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0189842
UMLS CUI [1,2]
C0011008
Abnormal cardiac conduction
Description

Abnormal cardiac conduction

Data type

boolean

Alias
UMLS CUI [1]
C0232219
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0232219
UMLS CUI [1,2]
C0011008
Bleeding
Description

Bleeding

Data type

boolean

Alias
UMLS CUI [1]
C0019080
Bleeding evaluation
Description

Bleeding evaluation

Data type

integer

Alias
UMLS CUI [1]
C0019080
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0011008
Complications due to site of access
Description

Complications due to site of access

Data type

boolean

Alias
UMLS CUI [1,1]
C0589360
UMLS CUI [1,2]
C0009566
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0589360
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C0011008
Paravalvular aortic insuffiency
Description

paravalvular aortic insuffiency

Data type

boolean

Alias
UMLS CUI [1]
C0003504
Paravalvular aortic insuffiency evaluation
Description

paravalvular aortic insuffiency evaluation

Data type

integer

Alias
UMLS CUI [1]
C0003504
Another aortic valve intervention
Description

Another aortic valve intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0003501
UMLS CUI [1,3]
C1517331
Intervention type
Description

Intervention type

Data type

integer

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0003501
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0003501
UMLS CUI [1,2]
C0011008
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Similar models

Endpoints NCT01539746

1 forms
  1. StudyEvent: ODM
    1. Endpoints NCT01539746
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of visit
C1320303 (UMLS CUI-1)
date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Endpoints
C2347784 (UMLS CUI-1)
Item
Death
integer
C0011065 (UMLS CUI [1])
death
Code List
Death
CL Item
No (0)
C1298908 (UMLS CUI-1)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
CL Item
due to cardiovascular issue (2)
C3887460 (UMLS CUI-1)
death date
Item
Date
date
C1148348 (UMLS CUI [1])
myocardial infarction
Item
Myocardial infarction
boolean
C0027051 (UMLS CUI [1])
myocardial infarction date
Item
Date
date
C0027051 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
TIA
Item
TIA
boolean
C0007787 (UMLS CUI [1])
TIA date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0007787 (UMLS CUI [1,2])
kidney failure
Item
Acute kidney failure
boolean
C0022660 (UMLS CUI [1])
Item
Grading
integer
C0022660 (UMLS CUI [1,1])
C0441799 (UMLS CUI [1,2])
kidney failure staging
Code List
Grading
CL Item
Grade I (1)
CL Item
Grad II (2)
CL Item
Grade III (3)
kidney failure date
Item
Date
date
C0022660 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
implantation of pacemaker
Item
Implantation of pacemaker (or if already implanted pacemaker - ventricular pacing < 10%)
boolean
C0189842 (UMLS CUI [1])
pacemaker date
Item
Date
date
C0189842 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
abnormal cardiac conduction
Item
Abnormal cardiac conduction
boolean
C0232219 (UMLS CUI [1])
abnormal cardiac conduction date
Item
Date
date
C0232219 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
bleeding
Item
Bleeding
boolean
C0019080 (UMLS CUI [1])
Item
Bleeding evaluation
integer
C0019080 (UMLS CUI [1])
bleeding evaluation
Code List
Bleeding evaluation
CL Item
mild (1)
C2945599 (UMLS CUI-1)
CL Item
severe (2)
C0205082 (UMLS CUI-1)
CL Item
life-threatening (3)
C2826244 (UMLS CUI-1)
bleeding date
Item
Date
date
C0019080 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
complications due to site of access
Item
Complications due to site of access
boolean
C0589360 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
complications site access date
Item
Date
date
C0589360 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
paravalvular aortic insuffiency
Item
Paravalvular aortic insuffiency
boolean
C0003504 (UMLS CUI [1])
Item
Paravalvular aortic insuffiency evaluation
integer
C0003504 (UMLS CUI [1])
paravalvular aortic insuffiency evaluation
Code List
Paravalvular aortic insuffiency evaluation
CL Item
mild (1)
C2945599 (UMLS CUI-1)
CL Item
moderate (2)
C0205081 (UMLS CUI-1)
CL Item
severe (3)
C0205082 (UMLS CUI-1)
another aortic valve intervention
Item
Another aortic valve intervention
boolean
C0543467 (UMLS CUI [1,1])
C0003501 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
Item
Intervention type
integer
C0543467 (UMLS CUI [1,1])
C0003501 (UMLS CUI [1,2])
intervention type
Code List
Intervention type
CL Item
TAVI (1)
C3702416 (UMLS CUI-1)
CL Item
OP (2)
intervention aortic valve date
Item
Date
date
C0003501 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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