ID

13297

Beschreibung

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: - Procedure day 0 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

Stichworte

Versionen (1)
  1. 01.02.16 01.02.16 -
Hochgeladen am

1. Februar 2016

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Procedure (day 0) SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746

Englisch

Procedure (day 0) NCT01539746

1 Formulare  
Date of visit
Beschreibung

Date of visit

Alias
UMLS CUI-1
C1320303
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Procedure
Beschreibung

Procedure

Alias
UMLS CUI-1
C0184661
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C2584899
Time of first puncture
Beschreibung

Time of first puncture

Datentyp

time

Alias
UMLS CUI [1,1]
C0034117
UMLS CUI [1,2]
C0449244
Time of suture of the vessel
Beschreibung

Time of suture of the vessel

Datentyp

time

Alias
UMLS CUI [1]
C0176683
Duration of the procedure
Beschreibung

Duration of the procedure

Datentyp

integer

Maßeinheiten
  • Min
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0184661
Min
Anaesthesia
Beschreibung

Anaesthesia

Datentyp

integer

Alias
UMLS CUI [1]
C0002903
Hemodynamic method
Beschreibung

Hemodynamic method

Datentyp

integer

Alias
UMLS CUI [1]
C0489837
Amount of contrast agent
Beschreibung

Amount of constrast agent

Datentyp

float

Maßeinheiten
  • ml
Alias
UMLS CUI [1]
C0009924
ml
Access type
Beschreibung

Access type

Datentyp

integer

Alias
UMLS CUI [1]
C0444454
Access localization
Beschreibung

Access localization

Datentyp

text

Alias
UMLS CUI [1,1]
C0475264
UMLS CUI [1,2]
C0444454
Closure path
Beschreibung

Closure path

Datentyp

integer

Alias
UMLS CUI [1]
C1521802
Additional PCI: due to complications
Beschreibung

Additional PCI: due to complications

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C1524062
Additional PCI: as part of the procedure
Beschreibung

Additional PCI: as part of the procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C1524062
Hemodynamics before implantation: blood pressure aorta systolic value
Beschreibung

Hemodynamics before implantation: blood pressure aorta systolic value

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0003483
mmHg
Hemodynamics before implantation: blood pressure aorta diastolic value
Beschreibung

Hemodynamics before implantation: blood pressure aorta diastolic value

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0003483
mmHg
Hemodynamics before implantation: systolic blood pressure left ventricular
Beschreibung

Hemodynamics before implantation: systolic blood pressure left ventricular

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0345054
mmHg
Hemodynamics before implantation: end-diastolic blood pressure left ventricular
Beschreibung

Hemodynamics before implantation: end-diastolic blood pressure left ventricular

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C1171395
mmHg
Randomisation
Beschreibung

Randomisation

Alias
UMLS CUI-1
C0034656
Treatment group after randomisation
Beschreibung

Treatment group after randomisation

Datentyp

text

Alias
UMLS CUI [1]
C1522541
Pre-dilation of valve
Beschreibung

Pre-dilation of valve

Alias
UMLS CUI-1
C2921035
UMLS CUI-2
C0332152
Pre-dilation of valve carried out
Beschreibung

Pre-dilation of valve carried out

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2921035
UMLS CUI [1,2]
C0332152
Balloon type
Beschreibung

Balloon type

Datentyp

integer

Alias
UMLS CUI [1]
C0441144
Dimension of the balloon - max. diameter
Beschreibung

Dimension of the balloon - max. diameter

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0441144
UMLS CUI [1,2]
C1301886
mm
Dimension of the balloon - length
Beschreibung

Dimension of the balloon - length

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0441144
UMLS CUI [1,2]
C1444754
cm
Number of balloons
Beschreibung

Number of balloons

Datentyp

integer

Alias
UMLS CUI [1,1]
C0441144
UMLS CUI [1,2]
C0449788
Number of dilatations
Beschreibung

Number of dilatations

Datentyp

integer

Alias
UMLS CUI [1,1]
C0004704
UMLS CUI [1,2]
C0449788
Overstimulation time
Beschreibung

Overstimulation time

Datentyp

integer

Maßeinheiten
  • sec
Alias
UMLS CUI [1]
C1709372
sec
Heart valve
Beschreibung

Heart valve

Alias
UMLS CUI-1
C0018826
Number CoreValves used
Beschreibung

Number CoreValves used

Datentyp

integer

Alias
UMLS CUI [1]
C0449788
Product
Beschreibung

Product

Datentyp

integer

Product name - Size
Beschreibung

Product name - Size

Datentyp

integer

Alias
UMLS CUI [1]
C0592499
Post-dilatation of valve
Beschreibung

Post-dilatation of valve

Alias
UMLS CUI-1
C2921035
UMLS CUI-2
C0687676
Post-dilatation of valve carried out
Beschreibung

Post-dilatation of valve carried out

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2921035
UMLS CUI [1,2]
C0687676
Balloon type
Beschreibung

Balloon type

Datentyp

integer

Dimension of the balloon - max. diameter
Beschreibung

Dimension of the balloon - max. diameter

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0441144
UMLS CUI [1,2]
C1301886
mm
Dimension of the balloon - length
Beschreibung

Dimension of the balloon - length

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0441144
UMLS CUI [1,2]
C1444754
cm
Number of balloons
Beschreibung

Number of balloons

Datentyp

integer

Alias
UMLS CUI [1,1]
C0441144
UMLS CUI [1,2]
C0449788
Number of dilatations
Beschreibung

Number of dilatations

Datentyp

integer

Alias
UMLS CUI [1,1]
C0004704
UMLS CUI [1,2]
C0449788
Overstimulation time
Beschreibung

Overstimulation time

Datentyp

integer

Maßeinheiten
  • sec
Alias
UMLS CUI [1]
C1709372
sec
Angiography after implantation - n.d.
Beschreibung

Angiography after implantation - n.d.

Datentyp

boolean

Alias
UMLS CUI [1]
C0085532
Implantant depth
Beschreibung

Implantant depth

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0525024
UMLS CUI [1,2]
C0205125
mm
Paravalvular aortic insuffiency
Beschreibung

Paravalvular aortic insuffiency

Datentyp

integer

Alias
UMLS CUI [1]
C0003504
Hemodynamics after implantation: blood pressure aorta systolic value
Beschreibung

Hemodynamics after implantation: blood pressure aorta systolic value

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0003483
mmHg
Hemodynamics after implantation: blood pressure aorta diastolic value
Beschreibung

Hemodynamics after implantation: blood pressure aorta diastolic value

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0003483
mmHg
Hemodynamics after implantation: systolic blood pressure left ventricular
Beschreibung

Hemodynamics after implantation: systolic blood pressure left ventricular

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0345054
mmHg
Hemodynamics after implantation: end-diastolic blood pressure left ventricular
Beschreibung

Hemodynamics after implantation: end-diastolic blood pressure left ventricular

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C1171395
mmHg
Complications
Beschreibung

Complications

Alias
UMLS CUI-1
C0009566
Success of procedure
Beschreibung

Success of procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C3258067
Complications during procedure
Beschreibung

Complications during procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0009566
Conversion to open heart surgery
Beschreibung

Conversion to open heart surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C3494226
Repositioning with "snare"
Beschreibung

Repositioning with "snare"

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0556030
UMLS CUI [1,2]
C0183362
Second heart valve ("valve-in-valve")
Beschreibung

Second heart valve ("valve-in-valve")

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018825
UMLS CUI [1,2]
C0205436
Dislocation heart valve
Beschreibung

Dislocation heart valve

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012691
UMLS CUI [1,2]
C0018826
Ventricular perforation
Beschreibung

Ventricular perforation

Datentyp

boolean

Alias
UMLS CUI [1]
C1710630
Cardiac tamponade
Beschreibung

Cardiac tamponade

Datentyp

boolean

Alias
UMLS CUI [1]
C0007177
Reanimation
Beschreibung

Reanimation

Datentyp

boolean

Alias
UMLS CUI [1]
C0007203
Ventricular fibrillation
Beschreibung

Ventricular fibrillation

Datentyp

boolean

Alias
UMLS CUI [1]
C0042510
Defibrillation
Beschreibung

Defibrillation

Datentyp

boolean

Alias
UMLS CUI [1]
C0013778
Allergic reaction
Beschreibung

Allergic reaction

Datentyp

boolean

Alias
UMLS CUI [1]
C1527304
Death
Beschreibung

Death

Datentyp

boolean

Alias
UMLS CUI [1]
C0011065
Stroke / TIA
Beschreibung

Stroke / TIA

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
Myocardial infarction
Beschreibung

Myocardial infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
Vascular complications
Beschreibung

Vascular complications

Datentyp

boolean

Alias
UMLS CUI [1]
C1393529
Vascular complication due to closure device
Beschreibung

Vascular complication due to closure device

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1393529
UMLS CUI [1,2]
C2825202
Implantation of covered stent
Beschreibung

Implantation of covered stent

Datentyp

boolean

Alias
UMLS CUI [1]
C1322797
Surgical closure
Beschreibung

Surgical closure

Datentyp

boolean

Alias
UMLS CUI [1]
C0185003
Bleeding
Beschreibung

Bleeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0019080
RBC transfusion in catheter laboratory
Beschreibung

RBC transfusion in catheter laboratory

Datentyp

boolean

Alias
UMLS CUI [1]
C0086252
Number of RBC transfusions
Beschreibung

Number of RBC transfusions

Datentyp

integer

Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C0449788
Other complication
Beschreibung

Other complication

Datentyp

boolean

Alias
UMLS CUI [1]
C0009566
Other
Beschreibung

Other

Datentyp

text

Alias
UMLS CUI [1]
C0009566
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Ähnliche Modelle

Procedure (day 0) NCT01539746

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date of visit
C1320303 (UMLS CUI-1)
date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Procedure
C0184661 (UMLS CUI-1)
date of procedure
Item
Date
date
C2584899 (UMLS CUI [1])
time first puncture
Item
Time of first puncture
time
C0034117 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
time of suture
Item
Time of suture of the vessel
time
C0176683 (UMLS CUI [1])
duration of procedure
Item
Duration of the procedure
integer
C0449238 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
Item
Anaesthesia
integer
C0002903 (UMLS CUI [1])
anaesthesia
Code List
Anaesthesia
CL Item
local (1)
C0002921 (UMLS CUI-1)
CL Item
sedation (2)
C0344106 (UMLS CUI-1)
CL Item
general anaesthetic (3)
C0002915 (UMLS CUI-1)
Item
Hemodynamic method
integer
C0489837 (UMLS CUI [1])
hemodynamic method
Code List
Hemodynamic method
CL Item
None (1)
C0549184 (UMLS CUI-1)
CL Item
Heart-lung machine (2)
C0018830 (UMLS CUI-1)
CL Item
ECMO (3)
C0015357 (UMLS CUI-1)
CL Item
LV assist device (4)
C0181598 (UMLS CUI-1)
contrast agent amount
Item
Amount of contrast agent
float
C0009924 (UMLS CUI [1])
Item
Access type
integer
C0444454 (UMLS CUI [1])
Access
Code List
Access type
CL Item
percutaneous (1)
C0522523 (UMLS CUI-1)
CL Item
surgical preparation (2)
C2038391 (UMLS CUI-1)
Item
Access localization
text
C0475264 (UMLS CUI [1,1])
C0444454 (UMLS CUI [1,2])
access localization
Code List
Access localization
CL Item
transfemoral (1)
C0879149 (UMLS CUI-1)
CL Item
trans-subclavicular (2)
C1096421 (UMLS CUI-1)
CL Item
transaortal (3)
C0442339 (UMLS CUI-1)
Item
Closure path
integer
C1521802 (UMLS CUI [1])
closure path
Code List
Closure path
CL Item
closure device (1)
C2825202 (UMLS CUI-1)
CL Item
surgical (2)
C0543467 (UMLS CUI-1)
CL Item
stent (3)
C0038257 (UMLS CUI-1)
additional PCI complications
Item
Additional PCI: due to complications
boolean
C1532338 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
additional PCI procedure
Item
Additional PCI: as part of the procedure
boolean
C1532338 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
systolic blood pressure aorta
Item
Hemodynamics before implantation: blood pressure aorta systolic value
integer
C0871470 (UMLS CUI [1,1])
C0003483 (UMLS CUI [1,2])
diastolic blood pressure aorta
Item
Hemodynamics before implantation: blood pressure aorta diastolic value
integer
C0428883 (UMLS CUI [1,1])
C0003483 (UMLS CUI [1,2])
systolic blood pressure left ventricular
Item
Hemodynamics before implantation: systolic blood pressure left ventricular
integer
C0871470 (UMLS CUI [1,1])
C0345054 (UMLS CUI [1,2])
end-diastolic blood pressure left ventricular
Item
Hemodynamics before implantation: end-diastolic blood pressure left ventricular
integer
C1171395 (UMLS CUI [1])
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Item
Treatment group after randomisation
text
C1522541 (UMLS CUI [1])
treatment group
Code List
Treatment group after randomisation
CL Item
TAVI with balloon dilatation (Group A)
CL Item
TAVI without balloon dilatation (Group B)
Item Group
Pre-dilation of valve
C2921035 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
pre-dilation of valve
Item
Pre-dilation of valve carried out
boolean
C2921035 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
Item
Balloon type
integer
C0441144 (UMLS CUI [1])
balloon type
Code List
Balloon type
CL Item
Nucleus (1)
CL Item
Z-Med (2)
CL Item
Tyshak (3)
CL Item
Osypka (4)
CL Item
other (5)
C0205394 (UMLS CUI-1)
diameter balloon
Item
Dimension of the balloon - max. diameter
integer
C0441144 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
length balloon
Item
Dimension of the balloon - length
integer
C0441144 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
number balloons
Item
Number of balloons
integer
C0441144 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
number dilatations
Item
Number of dilatations
integer
C0004704 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
overstimulation time
Item
Overstimulation time
integer
C1709372 (UMLS CUI [1])
Item Group
Heart valve
C0018826 (UMLS CUI-1)
number CoreValves
Item
Number CoreValves used
integer
C0449788 (UMLS CUI [1])
Item
Product
integer
product
Code List
Product
CL Item
CoreValve (1)
CL Item
Core Valve Evolut R (2)
Item
Product name - Size
integer
C0592499 (UMLS CUI [1])
product name
Code List
Product name - Size
CL Item
23 mm (1)
CL Item
26 mm (2)
CL Item
29 mm (3)
CL Item
31 mm (4)
Item Group
Post-dilatation of valve
C2921035 (UMLS CUI-1)
C0687676 (UMLS CUI-2)
post-dilatation of valve
Item
Post-dilatation of valve carried out
boolean
C2921035 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
Item
Balloon type
integer
balloon type
Code List
Balloon type
CL Item
Nucleus (1)
CL Item
Z-Med (2)
CL Item
Tyshak (3)
CL Item
Osypka (4)
CL Item
other (5)
C0205394 (UMLS CUI-1)
diameter balloon post
Item
Dimension of the balloon - max. diameter
integer
C0441144 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
length balloon post
Item
Dimension of the balloon - length
integer
C0441144 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
number balloons post
Item
Number of balloons
integer
C0441144 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
number dilatations post
Item
Number of dilatations
integer
C0004704 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
overstimulation time post
Item
Overstimulation time
integer
C1709372 (UMLS CUI [1])
angiography after implantation
Item
Angiography after implantation - n.d.
boolean
C0085532 (UMLS CUI [1])
implantant depth
Item
Implantant depth
integer
C0525024 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Item
Paravalvular aortic insuffiency
integer
C0003504 (UMLS CUI [1])
paravalvular aortic insuffiency
Code List
Paravalvular aortic insuffiency
CL Item
none (0)
C0549184 (UMLS CUI-1)
CL Item
slight (1)
C0750482 (UMLS CUI-1)
CL Item
medium (2)
C0439536 (UMLS CUI-1)
CL Item
severe (3)
C0205082 (UMLS CUI-1)
systolic blood pressure aorta post
Item
Hemodynamics after implantation: blood pressure aorta systolic value
integer
C0871470 (UMLS CUI [1,1])
C0003483 (UMLS CUI [1,2])
diastolic blood pressure aorta post
Item
Hemodynamics after implantation: blood pressure aorta diastolic value
integer
C0428883 (UMLS CUI [1,1])
C0003483 (UMLS CUI [1,2])
systolic blood pressure left ventricular post
Item
Hemodynamics after implantation: systolic blood pressure left ventricular
integer
C0871470 (UMLS CUI [1,1])
C0345054 (UMLS CUI [1,2])
end-diastolic blood pressure left ventricular post
Item
Hemodynamics after implantation: end-diastolic blood pressure left ventricular
integer
C1171395 (UMLS CUI [1])
Item Group
Complications
C0009566 (UMLS CUI-1)
success of procedure
Item
Success of procedure
boolean
C3258067 (UMLS CUI [1])
complications
Item
Complications during procedure
boolean
C0009566 (UMLS CUI [1])
conversion to open heart surgery
Item
Conversion to open heart surgery
boolean
C3494226 (UMLS CUI [1])
repositioning
Item
Repositioning with "snare"
boolean
C0556030 (UMLS CUI [1,1])
C0183362 (UMLS CUI [1,2])
valve-in-valve
Item
Second heart valve ("valve-in-valve")
boolean
C0018825 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
dislocation heart valve
Item
Dislocation heart valve
boolean
C0012691 (UMLS CUI [1,1])
C0018826 (UMLS CUI [1,2])
ventricular perforation
Item
Ventricular perforation
boolean
C1710630 (UMLS CUI [1])
cardiac tamponade
Item
Cardiac tamponade
boolean
C0007177 (UMLS CUI [1])
reanimation
Item
Reanimation
boolean
C0007203 (UMLS CUI [1])
ventricular fibrillation
Item
Ventricular fibrillation
boolean
C0042510 (UMLS CUI [1])
defibrillation
Item
Defibrillation
boolean
C0013778 (UMLS CUI [1])
allergic reaction
Item
Allergic reaction
boolean
C1527304 (UMLS CUI [1])
death
Item
Death
boolean
C0011065 (UMLS CUI [1])
stroke or TIA
Item
Stroke / TIA
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
myocardial infarction
Item
Myocardial infarction
boolean
C0027051 (UMLS CUI [1])
vascular complications
Item
Vascular complications
boolean
C1393529 (UMLS CUI [1])
vascular complication due to closure device
Item
Vascular complication due to closure device
boolean
C1393529 (UMLS CUI [1,1])
C2825202 (UMLS CUI [1,2])
covered stent
Item
Implantation of covered stent
boolean
C1322797 (UMLS CUI [1])
surgical closure
Item
Surgical closure
boolean
C0185003 (UMLS CUI [1])
bleeding
Item
Bleeding
boolean
C0019080 (UMLS CUI [1])
RBC transfusion
Item
RBC transfusion in catheter laboratory
boolean
C0086252 (UMLS CUI [1])
RBC transfusion number
Item
Number of RBC transfusions
integer
C0086252 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
other complication
Item
Other complication
boolean
C0009566 (UMLS CUI [1])
name of other complication
Item
Other
text
C0009566 (UMLS CUI [1])
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