Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis

Evaluation of the Safety and Clinical Performance of the Next-Generation SAFESYNC Balloon-Expandable Transcatheter Heart Valve in Patients With Severe Aortic Stenosis: A Prospective, Multicenter, Single-Arm Pivotal Study

The objective of this pivotal, prospective, multicenter, single-arm clinical trial is to evaluate the safety and clinical performance of the Next-Generation INOVARE® SAFESYNC Bioprosthetic Heart Valve, implanted via a transcatheter approach, in patients with severe aortic stenosis, an indication for TAVI, and intermediate or higher surgical risk. The study will enroll 40 participants.

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.