ID
13294
Descripción
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
Palabras clave
Versiones (2)
- 1/2/16 1/2/16 -
- 27/9/21 27/9/21 -
Subido en
1 de febrero de 2016
DOI
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Licencia
Creative Commons BY-NC 3.0
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Eligiblity Criteria SIMPLIFy TAVI Transcatheter Aortic Valve Implantation Without Predilation NCT01539746
Eligiblity Criteria NCT01539746
- StudyEvent: ODM
Descripción
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Descripción
LVEF ≤35%
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0428772
Descripción
Aortic valve stenosis with an aortic valve area <1 cm2 (<0,6 cm3/m2)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0003507
Descripción
Males or females at least 18 years of age
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0001779
Descripción
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)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3164744
Descripción
Signed informed consent
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0021430
Descripción
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
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%
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0162589
- UMLS CUI [2]
- C0004245
- UMLS CUI [3]
- C2016308
Descripción
Patients with implanted pacemaker because of AV block >= Degree II or Cardiac Resynchronization Therapy (CRT)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0030163
- UMLS CUI [2]
- C0004245
- UMLS CUI [3]
- C1167956
Descripción
Lack of written informed consent, severe mental disorder, drug/alcohol addiction
Tipo de datos
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
Descripción
Life expectancy < 1 year
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0023671
Descripción
Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, nitinol or sensitivity to contrast media that cannot be adequately premedicated
Tipo de datos
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
Descripción
Recent myocardial infarction (STEMI within the last 3 months)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0027051
Descripción
Left ventricular or atrial thrombus
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0587044
- UMLS CUI [2]
- C0741299
Descripción
Uncontrolled atrial fibrillation (heart rate > 140/Min)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0004238
- UMLS CUI [1,2]
- C0021311
Descripción
Mitral or tricuspidal valvular insufficiency (> grade II)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0026266
- UMLS CUI [2]
- C0040961
Descripción
Previous aortic valve replacement with mechanical valve
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0003506
Descripción
Evolutive or recent cerebrovascular event (within the last 3 months)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0038454
Descripción
Vascular conditions that make insertion and endovascular access to the aortic valve impossible
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0439801
- UMLS CUI [1,3]
- C2712690
Descripción
Symptomatic carotid or vertebral arterial narrowing (>70%) disease
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0007282
- UMLS CUI [2]
- C0042568
Descripción
Abdominal or thoracic aortic aneurysm in the path of the delivery system
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0162871
- UMLS CUI [2]
- C0162872
Descripción
Bleeding diathesis or contraindication to blood transfusion
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0005779
- UMLS CUI [2,1]
- C1301624
- UMLS CUI [2,2]
- C0005841
Descripción
Active gastritis or peptic ulcer disease
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0017152
- UMLS CUI [2]
- C0030920
Descripción
Severely impaired renal function, GFR < 30 ml/min
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1316377
Descripción
sepsis or acute endocarditis
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0243026
- UMLS CUI [2]
- C0375268
Descripción
Partition in another clinical trial
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2348568
Descripción
High probability of non-compliant study participation
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
Descripción
Pregnancy
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0032961
Similar models
Eligiblity Criteria NCT01539746
- StudyEvent: ODM
C0004245 (UMLS CUI [2])
C2016308 (UMLS CUI [3])
C0004245 (UMLS CUI [2])
C1167956 (UMLS CUI [3])
C1321605 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0009488 (UMLS CUI [2,3])
C0038586 (UMLS CUI [3])
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])
C0741299 (UMLS CUI [2])
C0021311 (UMLS CUI [1,2])
C0040961 (UMLS CUI [2])
C0439801 (UMLS CUI [1,2])
C2712690 (UMLS CUI [1,3])
C0042568 (UMLS CUI [2])
C0162872 (UMLS CUI [2])
C1301624 (UMLS CUI [2,1])
C0005841 (UMLS CUI [2,2])
C0030920 (UMLS CUI [2])
C0375268 (UMLS CUI [2])
C0439801 (UMLS CUI [1,2])