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.
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.
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.
Single group
INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve
DeviceParticipants will undergo TAVI via transfemoral access using the INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve and the B-Delivery System.
Device Success According to VARC-3 Criteria
Technical success; Absence of mortality; Absence of surgery or intervention related to the device or to major vascular, access-related, or cardiac structural complications; Intended valve performance, defined as mean transvalvular gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation.
Percentage of Participants Achieving Technical Success According to VARC-3 Criteria
Defined as freedom from mortality; successful vascular access, delivery of the device, and retrieval of the delivery system; correct positioning of a single prosthetic heart valve in the intended anatomical location; and freedom from surgery or intervention related to the device or to a major vascular, access-related, or cardiac structural complication. Results will be reported as the number and percentage of participants achieving technical success.
Incidence and Severity of Paravalvular Leak
Paravalvular leak will be assessed by transthoracic echocardiography and classified according to severity. The number and percentage of participants with paravalvular leak in each severity category will be reported.
Mean Transvalvular Aortic Pressure Gradient Assessed
Mean transvalvular aortic pressure gradient will be assessed by transthoracic echocardiography and reported in mmHg.
Distribution of Participants by New York Heart Association Functional Class
Functional status will be assessed using the New York Heart Association (NYHA) Functional Classification. The classification ranges from Class I to Class IV, where Class I represents no limitation of physical activity and Class IV represents inability to perform physical activity without symptoms and/or symptoms at rest. Higher NYHA classes indicate worse functional status. Results will be reported as the number and percentage of participants in each NYHA functional class.
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