TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3 (NCT02729519) | Clinical Trial Compass
CompletedNot Applicable
TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3
France250 participantsStarted 2016-06-08
Plain-language summary
Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence suggested that aortic valvuloplasty may be harmful and that high success rate may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation and using new generation balloon expandable prothesis is associated with a better net clinical benefit in comparison with procedure performed with pre dilatation.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Symptomatic Aortic valve stenosis with an aortic valve area \<1 cm2 (\<0,6 cm3/m2)
* Males or females of at least 18 years of age
* Logistic EuroSCORE ≥15% and/or a significant contraindication for open heart surgery (e.g., porcelain aorta or severe COPD) or all patients considered as having excessive surgical risk by the heart team
* Signed informed consent
* TAVI performed via transfemoral, sub clavicular or transaortic route with the SAPIEN 3 THV (Edwards Lifescience)
Exclusion Criteria:
* Transapical TAVI
* Preexisting aortic prosthesis (valve in valve technique)
* Vascular conditions that make insertion and endovascular access to the aortic valve impossible
* BAV performed for less than one week
* Recent myocardial infarction (STEMI within the last 3 months)
* Left ventricular or atrial thrombus by echocardiography
* Mitral or tricuspidal valvular insufficiency (\> grade II)
* Evolutive or recent cerebrovascular event (within the last 3 months)
* Symptomatic carotid or vertebral arterial narrowing (\>70%) disease
* Bleeding diathesis or coagulopathy or patient refusing blood transfusion
* 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, or sensitivity to contrast media that cannot be adequately premedicated
* Participation in another drug or device study that would jeopardize the appropriate…