There are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day and 2-year follow-up.
Important improvements in aortic valve prostheses technology has been made aiming comparable performance of these prosthesis to surgical valve ones. The experience with the early generation of aortic valve prostheses revealed some important differences regarding the incidence of paravalvular leakage, need for pacemaker or valve thrombosis among them. Currently the new generations of valve prostheses such as Sapien 3 balloon-expandable valve and Lotus, repositionable valve are the most frequently used devices. There are registry data about the clinical performance of these valve types but a randomized comparison is missing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
116
repositionable valve prosthesis implanted via trans-femoral and trans-catheter route
balloon-expandable valve prosthesis implanted via trans-femoral and trans-catheter route
Munich University Clinic, Ludwig-Maximilians University
Munich, Bavaria, Germany
Segeberger Kliniken Gmbh
Bad Segeberg, Schleswig-Holstein, Germany
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy
Incidence of new permanent pacemaker implantation
implantation of PM
Time frame: 30 days
incidence of any prosthesis regurgitation
prosthesis regurgitation in echocardiography
Time frame: 30 days
Incidence of any conduction abnormalities
conduction abnormalities on rest ECG
Time frame: 30 days
Device success rate according to VARC-2 definition
combined endpoint
Time frame: 30 days
Mortality rate
all-cause death
Time frame: 30 days
Mortality rate
all-cause death
Time frame: 1 year
Mortality rate
all-cause death
Time frame: 2 years
incidence of early safety parameters according to VARC-2 definitions
combined endpoint
Time frame: 30 days
incidence of combined efficacy according to VARC-2 definitions
combined endpoint
Time frame: 1 year
incidence of combined efficacy according to VARC-2 definitions
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combined endpoint
Time frame: 2 years