Study design: single arm, interventional and multicenter study. The objectives are evaluate Safety and efficacy of TAVI in Department of Cardiology without on site cardiac Surgery for symptomatic severe aortic valve stenosis by expert operator team, in patients with prohibitive surgical risk. For the pilot phase, 20 patients will be enrolled. For whole study, all consecutive patients undergoing TAVI in center without CS on site will be enrolled to reach a number of about 200 patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
ranscatheter aortic valve implantation, a percutaneous treatment for severe aortic valve stenosis, is increasingly performed worldwide. The pacemaker should be able to perform overdrive pacing which is essential to reduce cardiac output and transvalvular blood flow which are critical during balloon aortic valvuloplasty and valve deployment of the balloon- expandable valve. Minor adjustment may be needed for ideal positioning, but importantly this has to be done before valve implantation
Ospedale Generale Regionale F Miulli
Acquaviva delle Fonti, Bari, Italy
RECRUITINGAUSL Romagna Morgagni - Pierantoni Hospital
Forlì, Emilia-Romagna, Italy
RECRUITINGOspedale Santa Maria della Croci
Ravenna, Italy
RECRUITINGHospital del Mar
Barcelona, Spain
RECRUITINGnumber of all cause death patients in 30 days following TAVI/total TAVI patients
the simple size calculation is based on the primary endpoint mortality at 30 days. Considering a standard incidence of 6-7% 200 patients will be needed to demonstrate, wuth an alpha error of 5% the non inferiority of the alternative treatment compared to the standard considering a non inferiory margin of 3% such as to exclude mortaluty values higher than 10%, in relation at the upper limit of the 90% confidence interval calculated with the exact method of clopper and Pearson.
Time frame: 4 weeks
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