ID
13297
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: - 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
Keywords
Versions (1)
- 2/1/16 2/1/16 -
Uploaded on
February 1, 2016
DOI
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License
Creative Commons BY-NC 3.0
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Procedure (day 0) SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746
Procedure (day 0) NCT01539746
- StudyEvent: ODM
Description
Procedure
Alias
- UMLS CUI-1
- C0184661
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C2584899
Description
Time of first puncture
Data type
time
Alias
- UMLS CUI [1,1]
- C0034117
- UMLS CUI [1,2]
- C0449244
Description
Time of suture of the vessel
Data type
time
Alias
- UMLS CUI [1]
- C0176683
Description
Duration of the procedure
Data type
integer
Measurement units
- Min
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C0184661
Description
Anaesthesia
Data type
integer
Alias
- UMLS CUI [1]
- C0002903
Description
Hemodynamic method
Data type
integer
Alias
- UMLS CUI [1]
- C0489837
Description
Amount of constrast agent
Data type
float
Measurement units
- ml
Alias
- UMLS CUI [1]
- C0009924
Description
Access type
Data type
integer
Alias
- UMLS CUI [1]
- C0444454
Description
Access localization
Data type
text
Alias
- UMLS CUI [1,1]
- C0475264
- UMLS CUI [1,2]
- C0444454
Description
Closure path
Data type
integer
Alias
- UMLS CUI [1]
- C1521802
Description
Additional PCI: due to complications
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1532338
- UMLS CUI [1,2]
- C1524062
Description
Additional PCI: as part of the procedure
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1532338
- UMLS CUI [1,2]
- C1524062
Description
Hemodynamics before implantation: blood pressure aorta systolic value
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0003483
Description
Hemodynamics before implantation: blood pressure aorta diastolic value
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0003483
Description
Hemodynamics before implantation: systolic blood pressure left ventricular
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0345054
Description
Hemodynamics before implantation: end-diastolic blood pressure left ventricular
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C1171395
Description
Randomisation
Alias
- UMLS CUI-1
- C0034656
Description
Pre-dilation of valve
Alias
- UMLS CUI-1
- C2921035
- UMLS CUI-2
- C0332152
Description
Pre-dilation of valve carried out
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2921035
- UMLS CUI [1,2]
- C0332152
Description
Balloon type
Data type
integer
Alias
- UMLS CUI [1]
- C0441144
Description
Dimension of the balloon - max. diameter
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0441144
- UMLS CUI [1,2]
- C1301886
Description
Dimension of the balloon - length
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0441144
- UMLS CUI [1,2]
- C1444754
Description
Number of balloons
Data type
integer
Alias
- UMLS CUI [1,1]
- C0441144
- UMLS CUI [1,2]
- C0449788
Description
Number of dilatations
Data type
integer
Alias
- UMLS CUI [1,1]
- C0004704
- UMLS CUI [1,2]
- C0449788
Description
Overstimulation time
Data type
integer
Measurement units
- sec
Alias
- UMLS CUI [1]
- C1709372
Description
Heart valve
Alias
- UMLS CUI-1
- C0018826
Description
Post-dilatation of valve
Alias
- UMLS CUI-1
- C2921035
- UMLS CUI-2
- C0687676
Description
Post-dilatation of valve carried out
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2921035
- UMLS CUI [1,2]
- C0687676
Description
Balloon type
Data type
integer
Description
Dimension of the balloon - max. diameter
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0441144
- UMLS CUI [1,2]
- C1301886
Description
Dimension of the balloon - length
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0441144
- UMLS CUI [1,2]
- C1444754
Description
Number of balloons
Data type
integer
Alias
- UMLS CUI [1,1]
- C0441144
- UMLS CUI [1,2]
- C0449788
Description
Number of dilatations
Data type
integer
Alias
- UMLS CUI [1,1]
- C0004704
- UMLS CUI [1,2]
- C0449788
Description
Overstimulation time
Data type
integer
Measurement units
- sec
Alias
- UMLS CUI [1]
- C1709372
Description
Angiography after implantation - n.d.
Data type
boolean
Alias
- UMLS CUI [1]
- C0085532
Description
Implantant depth
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0525024
- UMLS CUI [1,2]
- C0205125
Description
Paravalvular aortic insuffiency
Data type
integer
Alias
- UMLS CUI [1]
- C0003504
Description
Hemodynamics after implantation: blood pressure aorta systolic value
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0003483
Description
Hemodynamics after implantation: blood pressure aorta diastolic value
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0003483
Description
Hemodynamics after implantation: systolic blood pressure left ventricular
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0345054
Description
Hemodynamics after implantation: end-diastolic blood pressure left ventricular
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C1171395
Description
Complications
Alias
- UMLS CUI-1
- C0009566
Description
Success of procedure
Data type
boolean
Alias
- UMLS CUI [1]
- C3258067
Description
Complications during procedure
Data type
boolean
Alias
- UMLS CUI [1]
- C0009566
Description
Conversion to open heart surgery
Data type
boolean
Alias
- UMLS CUI [1]
- C3494226
Description
Repositioning with "snare"
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0556030
- UMLS CUI [1,2]
- C0183362
Description
Second heart valve ("valve-in-valve")
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0018825
- UMLS CUI [1,2]
- C0205436
Description
Dislocation heart valve
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012691
- UMLS CUI [1,2]
- C0018826
Description
Ventricular perforation
Data type
boolean
Alias
- UMLS CUI [1]
- C1710630
Description
Cardiac tamponade
Data type
boolean
Alias
- UMLS CUI [1]
- C0007177
Description
Reanimation
Data type
boolean
Alias
- UMLS CUI [1]
- C0007203
Description
Ventricular fibrillation
Data type
boolean
Alias
- UMLS CUI [1]
- C0042510
Description
Defibrillation
Data type
boolean
Alias
- UMLS CUI [1]
- C0013778
Description
Allergic reaction
Data type
boolean
Alias
- UMLS CUI [1]
- C1527304
Description
Death
Data type
boolean
Alias
- UMLS CUI [1]
- C0011065
Description
Stroke / TIA
Data type
boolean
Alias
- UMLS CUI [1]
- C0038454
- UMLS CUI [2]
- C0007787
Description
Myocardial infarction
Data type
boolean
Alias
- UMLS CUI [1]
- C0027051
Description
Vascular complications
Data type
boolean
Alias
- UMLS CUI [1]
- C1393529
Description
Vascular complication due to closure device
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1393529
- UMLS CUI [1,2]
- C2825202
Description
Implantation of covered stent
Data type
boolean
Alias
- UMLS CUI [1]
- C1322797
Description
Surgical closure
Data type
boolean
Alias
- UMLS CUI [1]
- C0185003
Description
Bleeding
Data type
boolean
Alias
- UMLS CUI [1]
- C0019080
Description
RBC transfusion in catheter laboratory
Data type
boolean
Alias
- UMLS CUI [1]
- C0086252
Description
Number of RBC transfusions
Data type
integer
Alias
- UMLS CUI [1,1]
- C0086252
- UMLS CUI [1,2]
- C0449788
Description
Other complication
Data type
boolean
Alias
- UMLS CUI [1]
- C0009566
Description
Other
Data type
text
Alias
- UMLS CUI [1]
- C0009566
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Procedure (day 0) NCT01539746
- StudyEvent: ODM
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