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44675

Beskrivning

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: - Baseline 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

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Versioner (2)
  1. 01/02/16 01/02/16 -
  2. 27/09/21 27/09/21 -
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27 settembre 2021

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

    Engelsk

    Eligiblity Criteria NCT01539746

    1 Formulär  
    Date of visit
    Beskrivning

    Date of visit

    Alias
    UMLS CUI-1
    C1320303
    Date of visit
    Beskrivning

    Date of visit

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    LVEF ≤35%
    Beskrivning

    LVEF ≤35%

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    Aortic valve stenosis with an aortic valve area <1 cm2 (<0,6 cm3/m2)
    Beskrivning

    Aortic valve stenosis with an aortic valve area <1 cm2 (<0,6 cm3/m2)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0003507
    Males or females at least 18 years of age
    Beskrivning

    Males or females at least 18 years of age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Logistic EuroSCORE ≥15% and age ≥75 years or if age <75 years: logistic EuroSCORE ≥20% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD)
    Beskrivning

    Logistic EuroSCORE ≥15% and age ≥75 years or if age <75 years: logistic EuroSCORE ≥20% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3164744
    Signed informed consent
    Beskrivning

    Signed informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator) with atrioventricular block >= 1. degree and ventricular pacing rate > 10%
    Beskrivning

    Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator) with atrioventricular block >= 1. degree and ventricular pacing rate > 10%

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0162589
    UMLS CUI [2]
    C0004245
    UMLS CUI [3]
    C2016308
    Patients with implanted pacemaker because of AV block >= Degree II or Cardiac Resynchronization Therapy (CRT)
    Beskrivning

    Patients with implanted pacemaker because of AV block >= Degree II or Cardiac Resynchronization Therapy (CRT)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0030163
    UMLS CUI [2]
    C0004245
    UMLS CUI [3]
    C1167956
    Lack of written informed consent, severe mental disorder, drug/alcohol addiction
    Beskrivning

    Lack of written informed consent, severe mental disorder, drug/alcohol addiction

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2,1]
    C1321605
    UMLS CUI [2,2]
    C0439801
    UMLS CUI [2,3]
    C0009488
    UMLS CUI [3]
    C0038586
    Life expectancy < 1 year
    Beskrivning

    Life expectancy < 1 year

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, nitinol or sensitivity to contrast media that cannot be adequately premedicated
    Beskrivning

    Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, nitinol or sensitivity to contrast media that cannot be adequately premedicated

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0004057
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0019134
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0040207
    UMLS CUI [4,1]
    C0020517
    UMLS CUI [4,2]
    C0070166
    UMLS CUI [5,1]
    C0020517
    UMLS CUI [5,2]
    C0068790
    UMLS CUI [6,1]
    C0020517
    UMLS CUI [6,2]
    C0009924
    Recent myocardial infarction (STEMI within the last 3 months)
    Beskrivning

    Recent myocardial infarction (STEMI within the last 3 months)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    Left ventricular or atrial thrombus
    Beskrivning

    Left ventricular or atrial thrombus

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0587044
    UMLS CUI [2]
    C0340517
    Uncontrolled atrial fibrillation (heart rate > 140/Min)
    Beskrivning

    Uncontrolled atrial fibrillation (heart rate > 140/Min)

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0004238
    UMLS CUI [1,2]
    C0009450
    Mitral or tricuspidal valvular insufficiency (> grade II)
    Beskrivning

    Mitral or tricuspidal valvular insufficiency (> grade II)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0026266
    UMLS CUI [2]
    C0040961
    Previous aortic valve replacement with mechanical valve
    Beskrivning

    Previous aortic valve replacement with mechanical valve

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0003506
    Evolutive or recent cerebrovascular event (within the last 3 months)
    Beskrivning

    Evolutive or recent cerebrovascular event (within the last 3 months)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0038454
    Vascular conditions that make insertion and endovascular access to the aortic valve impossible
    Beskrivning

    Vascular conditions that make insertion and endovascular access to the aortic valve impossible

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C2712690
    Symptomatic carotid or vertebral arterial narrowing (>70%) disease
    Beskrivning

    Symptomatic carotid or vertebral arterial narrowing (>70%) disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0007282
    UMLS CUI [2]
    C0042568
    Abdominal or thoracic aortic aneurysm in the path of the delivery system
    Beskrivning

    Abdominal or thoracic aortic aneurysm in the path of the delivery system

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0162871
    UMLS CUI [2]
    C0162872
    Bleeding diathesis or contraindication to blood transfusion
    Beskrivning

    Bleeding diathesis or contraindication to blood transfusion

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005779
    UMLS CUI [2,1]
    C1301624
    UMLS CUI [2,2]
    C0005841
    Active gastritis or peptic ulcer disease
    Beskrivning

    Active gastritis or peptic ulcer disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0017152
    UMLS CUI [2]
    C0030920
    Severely impaired renal function, GFR < 30 ml/min
    Beskrivning

    Severely impaired renal function, GFR < 30 ml/min

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1316377
    Sepsis including acute endocarditis
    Beskrivning

    sepsis or acute endocarditis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0243026
    UMLS CUI [2]
    C0375268
    Partition in another clinical trial
    Beskrivning

    Partition in another clinical trial

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    High probability of non-compliant study participation
    Beskrivning

    High probability of non-compliant study participation

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    Pregnancy
    Beskrivning

    Pregnancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
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    Similar models

    Eligiblity Criteria NCT01539746

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Date of visit
    C1320303 (UMLS CUI-1)
    date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    LVEF
    Item
    LVEF ≤35%
    boolean
    C0428772 (UMLS CUI [1])
    aortic valve stenosis
    Item
    Aortic valve stenosis with an aortic valve area <1 cm2 (<0,6 cm3/m2)
    boolean
    C0003507 (UMLS CUI [1])
    age
    Item
    Males or females at least 18 years of age
    boolean
    C0001779 (UMLS CUI [1])
    logistic euroSCORE
    Item
    Logistic EuroSCORE ≥15% and age ≥75 years or if age <75 years: logistic EuroSCORE ≥20% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD)
    boolean
    C3164744 (UMLS CUI [1])
    signed informed consent
    Item
    Signed informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    ICD
    Item
    Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator) with atrioventricular block >= 1. degree and ventricular pacing rate > 10%
    boolean
    C0162589 (UMLS CUI [1])
    C0004245 (UMLS CUI [2])
    C2016308 (UMLS CUI [3])
    implanted pacemaker or CRT
    Item
    Patients with implanted pacemaker because of AV block >= Degree II or Cardiac Resynchronization Therapy (CRT)
    boolean
    C0030163 (UMLS CUI [1])
    C0004245 (UMLS CUI [2])
    C1167956 (UMLS CUI [3])
    mental disorder or drug addiction
    Item
    Lack of written informed consent, severe mental disorder, drug/alcohol addiction
    boolean
    C0021430 (UMLS CUI [1])
    C1321605 (UMLS CUI [2,1])
    C0439801 (UMLS CUI [2,2])
    C0009488 (UMLS CUI [2,3])
    C0038586 (UMLS CUI [3])
    life expectancy
    Item
    Life expectancy < 1 year
    boolean
    C0023671 (UMLS CUI [1])
    hypersensibility or contraindication
    Item
    Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, nitinol or sensitivity to contrast media that cannot be adequately premedicated
    boolean
    C0020517 (UMLS CUI [1,1])
    C0004057 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0019134 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3,1])
    C0040207 (UMLS CUI [3,2])
    C0020517 (UMLS CUI [4,1])
    C0070166 (UMLS CUI [4,2])
    C0020517 (UMLS CUI [5,1])
    C0068790 (UMLS CUI [5,2])
    C0020517 (UMLS CUI [6,1])
    C0009924 (UMLS CUI [6,2])
    myocardial infarction
    Item
    Recent myocardial infarction (STEMI within the last 3 months)
    boolean
    C0027051 (UMLS CUI [1])
    left ventricular or atrial thrombus
    Item
    Left ventricular or atrial thrombus
    boolean
    C0587044 (UMLS CUI [1])
    C0340517 (UMLS CUI [2])
    uncontrolled atrial fibrillation
    Item
    Uncontrolled atrial fibrillation (heart rate > 140/Min)
    boolean
    C0004238 (UMLS CUI [1,1])
    C0009450 (UMLS CUI [1,2])
    mitral or tricuspidal valvular insufficiency
    Item
    Mitral or tricuspidal valvular insufficiency (> grade II)
    boolean
    C0026266 (UMLS CUI [1])
    C0040961 (UMLS CUI [2])
    aortic valve replacement
    Item
    Previous aortic valve replacement with mechanical valve
    boolean
    C0003506 (UMLS CUI [1])
    cerebrovascular event
    Item
    Evolutive or recent cerebrovascular event (within the last 3 months)
    boolean
    C0038454 (UMLS CUI [1])
    inadequate catheter
    Item
    Vascular conditions that make insertion and endovascular access to the aortic valve impossible
    boolean
    C0021430 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C2712690 (UMLS CUI [1,3])
    symptomatic carotid
    Item
    Symptomatic carotid or vertebral arterial narrowing (>70%) disease
    boolean
    C0007282 (UMLS CUI [1])
    C0042568 (UMLS CUI [2])
    abdominal or thoracic aortic aneurysm
    Item
    Abdominal or thoracic aortic aneurysm in the path of the delivery system
    boolean
    C0162871 (UMLS CUI [1])
    C0162872 (UMLS CUI [2])
    bleeding diathesis
    Item
    Bleeding diathesis or contraindication to blood transfusion
    boolean
    C0005779 (UMLS CUI [1])
    C1301624 (UMLS CUI [2,1])
    C0005841 (UMLS CUI [2,2])
    active gastritis or peptic ulcer disease
    Item
    Active gastritis or peptic ulcer disease
    boolean
    C0017152 (UMLS CUI [1])
    C0030920 (UMLS CUI [2])
    renal function
    Item
    Severely impaired renal function, GFR < 30 ml/min
    boolean
    C1316377 (UMLS CUI [1])
    sepsis or acute endocarditis
    Item
    Sepsis including acute endocarditis
    boolean
    C0243026 (UMLS CUI [1])
    C0375268 (UMLS CUI [2])
    partition in another trial
    Item
    Partition in another clinical trial
    boolean
    C2348568 (UMLS CUI [1])
    limited compliance expectable
    Item
    High probability of non-compliant study participation
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    pregnancy
    Item
    Pregnancy
    boolean
    C0032961 (UMLS CUI [1])
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