Transcatheter Aortic Valve Implantation Without Predilation
Germany110 participantsStarted 2013-01-09
Plain-language summary
The purpose of this study is to demonstrate that the avoidance of balloon valvuloplasty for predilation of the native aortic valve is associated with a reduction of the composite primary endpoint in TAVI patients with severely impaired left-ventricular ejection fraction (LVEF ≤35%).
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion Criteria:
* LVEF ≤35%
* Aortic valve stenosis with an aortic valve area \<1 cm2 (\<0,6 cm3/m2)
* Males or females at least 18 years of age
* 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)
* Signed informed consent
Exclusion Criteria:
* Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator)
* Patients with a pre-existing class I or class II indication for new pacemaker implantation according to the 2007 ESC guidelines
* Lack of written informed consent, severe mental disorder, drug/alcohol addiction
* Life expectancy \< 1 year
* Hypersensitivity or contraindication to acetyl salicyl acid, heparin, ticlopidine, clopidogrel, nitinol or sensitivity to contrast media that cannot be adequately premedicated
* Recent myocardial infarction (STEMI within the last 3 months)
* Left ventricular or atrial thrombus by echocardiography
* Uncontrolled atrial fibrillation
* Mitral or tricuspidal valvular insufficiency (\> grade II)
* Previous aortic valve replacement with mechanical valve
* Evolutive or recent cerebrovascular event (within the last 3 months)
* Vascular conditions that make insertion and endovascular access to the aortic valve impossible
* Symptomatic carotid or vertebral arterial narrowing (\>70%) disease
* Abdominal or thoracic aortic aneurysm in the p…