Can a new heart valve offer a safer fix for aortic stenosis?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Severe aortic valve stenosis diagnosed according to criteria established in current guidelines. * Intermediate or higher surgical risk, defined as a Society of Thoracic Surgeons (STS) score ≥4%. * Indication for transcatheter aortic valve implantation (TAVI). * Willing and able to participate in the study and provide written informed consent. Exclusion Criteria: * Any condition considered a contraindication to implantation of a bioprosthetic heart valve (e.g., indication for a mechanical heart valve). * Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, nitinol (titanium or nickel), or contrast media that cannot be adequately managed with premedication. This includes heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia with thrombosis (HITTS). * Blood dyscrasias, including leukopenia (white blood cell count \<1,000/mm³), thrombocytopenia (platelet count \<100,000 cells/mm³), history of coagulopathy, or hypercoagulable states. * Active infection, including endocarditis. * Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or requirement for mechanical hemodynamic support. * Stroke or transient ischemic attack (TIA) within 2 months prior to the index procedure. * History of gastrointestinal bleeding or other bleeding that precludes anticoagulant or antiplatelet therapy. * Estimated life expectancy of less than 24 months. * Other medical, social, or psychological conditions that, in the investigator's opinion, may prevent the participant from providing informed consent or adequately complying with the study protocol. * Pre-existing prosthetic heart valve, either biological or mechanical, in the aortic position. * Concomitant severe mitral or tricuspid valve disease. * Hypertrophic obstructive cardiomyopathy. * Successful percutaneous coronary intervention (PCI) performed within 48 hours prior to TAVI. * Femoral artery diameter \<5.5 mm for SAFESYNC 20-24 mm, \<6.0 mm for SAFESYNC 26-28 mm, or \<6.5 mm for SAFESYNC 30 mm. * High risk of aortic annular rupture or significant residual paravalvular leak due to severe calcification of the aortic valve or left ventricular outflow tract. * High risk of coronary obstruction, defined by computed tomography angiography as coronary ostial height \<10 mm with narrow sinuses of Valsalva (SOV), with a mean SOV diameter \<3 mm greater than the bioprosthetic valve size. * Left ventricular dysfunction with left ventricular ejection fraction (LVEF) ≤30%. * Severe chronic kidney disease, defined as glomerular filtration rate (GFR) \<30 mL/min/1.73 m².