Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Interme… (NCT03112980) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality
Germany1,414 participantsStarted 2017-05-10
Plain-language summary
Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality in a 1:1 fashion to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) to test, whether TAVI is non-inferior to SAVR, as measured by all-cause mortality or stroke after 1 and 5 years.
Who can participate
Age range65 Years – 85 Years
SexALL
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Inclusion criteria
✓. Heart team consensus that TAVI and SAVR are both medically justified and advisable based on:
✓. Degenerative aortic valve stenosis with echocardiographically derived criteria:
✓. Patient is symptomatic from his/her aortic valve stenosis
✓. Patient is classified as low to intermediate operative risk as assessed by the local heart team according to the variables outlined in the 2017 ESC/EACTS Guidelines for the Management of valvular heart disease, taking into account cardiac and extracardiac Patient characteristics and established risk scores (e.g. STS-PROM, EuroSCORE).
✓. A transfemoral or alternative (e.g. transapical, transaortic, transaxillary) access for TAVI seems feasible. Centers should follow a "transfemoral first" strategy for the primary route of access; however, other routes of access are also allowed, as decided by local heart team consensus.
✓. Patient has provided written informed consent to participate in the trial.
✓. Ability of the patient to understand the patient information and to personally sign and date the informed consent to participate in the study, before performing any study related procedures.
✓. The patient agrees to undergo SAVR, if randomized to control treatment.
Exclusion criteria
✕. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
✕. Untreated clinically significant coronary artery disease considered a contraindication to an isolated aortic valve procedure (TAVI or SAVR) according to heart team consensus