ID
13294
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: - 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
Stichworte
Versionen (2)
- 01.02.16 01.02.16 -
- 27.09.21 27.09.21 -
Hochgeladen am
1. Februar 2016
DOI
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Lizenz
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
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
LVEF ≤35%
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0428772
Beschreibung
Aortic valve stenosis with an aortic valve area <1 cm2 (<0,6 cm3/m2)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0003507
Beschreibung
Males or females at least 18 years of age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
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)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3164744
Beschreibung
Signed informed consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
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%
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0162589
- UMLS CUI [2]
- C0004245
- UMLS CUI [3]
- C2016308
Beschreibung
Patients with implanted pacemaker because of AV block >= Degree II or Cardiac Resynchronization Therapy (CRT)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030163
- UMLS CUI [2]
- C0004245
- UMLS CUI [3]
- C1167956
Beschreibung
Lack of written informed consent, severe mental disorder, drug/alcohol addiction
Datentyp
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
Beschreibung
Life expectancy < 1 year
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023671
Beschreibung
Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, nitinol or sensitivity to contrast media that cannot be adequately premedicated
Datentyp
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
Beschreibung
Recent myocardial infarction (STEMI within the last 3 months)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0027051
Beschreibung
Left ventricular or atrial thrombus
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0587044
- UMLS CUI [2]
- C0741299
Beschreibung
Uncontrolled atrial fibrillation (heart rate > 140/Min)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0004238
- UMLS CUI [1,2]
- C0021311
Beschreibung
Mitral or tricuspidal valvular insufficiency (> grade II)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0026266
- UMLS CUI [2]
- C0040961
Beschreibung
Previous aortic valve replacement with mechanical valve
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0003506
Beschreibung
Evolutive or recent cerebrovascular event (within the last 3 months)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038454
Beschreibung
Vascular conditions that make insertion and endovascular access to the aortic valve impossible
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0439801
- UMLS CUI [1,3]
- C2712690
Beschreibung
Symptomatic carotid or vertebral arterial narrowing (>70%) disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0007282
- UMLS CUI [2]
- C0042568
Beschreibung
Abdominal or thoracic aortic aneurysm in the path of the delivery system
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0162871
- UMLS CUI [2]
- C0162872
Beschreibung
Bleeding diathesis or contraindication to blood transfusion
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005779
- UMLS CUI [2,1]
- C1301624
- UMLS CUI [2,2]
- C0005841
Beschreibung
Active gastritis or peptic ulcer disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0017152
- UMLS CUI [2]
- C0030920
Beschreibung
Severely impaired renal function, GFR < 30 ml/min
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1316377
Beschreibung
sepsis or acute endocarditis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0243026
- UMLS CUI [2]
- C0375268
Beschreibung
Partition in another clinical trial
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
High probability of non-compliant study participation
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
Beschreibung
Pregnancy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0032961
Ähnliche Modelle
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])