ID

44675

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: - 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

Keywords

Versions (2)
  1. 2/1/16 2/1/16 -
  2. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

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

English

Eligiblity Criteria NCT01539746

1 forms  
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
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
LVEF ≤35%
Description

LVEF ≤35%

Data type

boolean

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

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

Data type

boolean

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

Males or females at least 18 years of age

Data type

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)
Description

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)

Data type

boolean

Alias
UMLS CUI [1]
C3164744
Signed informed consent
Description

Signed informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

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%
Description

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%

Data type

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)
Description

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

Data type

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
Description

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

Data type

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
Description

Life expectancy < 1 year

Data type

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
Description

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

Data type

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)
Description

Recent myocardial infarction (STEMI within the last 3 months)

Data type

boolean

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

Left ventricular or atrial thrombus

Data type

boolean

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

Uncontrolled atrial fibrillation (heart rate > 140/Min)

Data type

boolean

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

Mitral or tricuspidal valvular insufficiency (> grade II)

Data type

boolean

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

Previous aortic valve replacement with mechanical valve

Data type

boolean

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

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

Data type

boolean

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

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

Data type

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
Description

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

Data type

boolean

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

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

Data type

boolean

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

Bleeding diathesis or contraindication to blood transfusion

Data type

boolean

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

Active gastritis or peptic ulcer disease

Data type

boolean

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

Severely impaired renal function, GFR < 30 ml/min

Data type

boolean

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

sepsis or acute endocarditis

Data type

boolean

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

Partition in another clinical trial

Data type

boolean

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

High probability of non-compliant study participation

Data type

boolean

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

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligiblity Criteria NCT01539746

1 forms
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
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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