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

N/ANot Yet RecruitingNCT07806409

Braile Biomedica Ind. Com. e Repr. Ltda.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Stenosis Senile Aortic Stenosis Symptomatic Aortic Stenosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 30 days after the procedure

Secondary Outcomes

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.

Time frame: During the procedure

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.