Aortic Stenosis, Aortic Stenosis Senile, Aortic Stenosis Symptomatic
Conditions
Keywords
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, TAVI, Balloon-Expandable Transcatheter Heart Valve
Brief summary
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.
Interventions
DEVICEINOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve
Participants will undergo TAVI via transfemoral access using the INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve and the B-Delivery System.
Sponsors
Braile Biomedica Ind. Com. e Repr. Ltda.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Success According to VARC-3 Criteria | 30 days after the procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Technical Success According to VARC-3 Criteria | During the procedure | 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 | 30 days, 6 months, 12 months, and annually through 5 years | 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 | 30 days, 6 months, 12 months, and annually through 5 years | 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 | 30 days, 6 months, 12 months, and annually through 5 years | 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. |
| Incidence of New Permanent Pacemaker Implantation | 30 days, 6 months, 12 months, and annually through 5 years | New permanent pacemaker implantation following the index transcatheter aortic valve implantation procedure will be assessed. Results will be reported as the number and percentage of participants who undergo new permanent pacemaker implantation. |
| Incidence of All-Cause Mortality | 30 days, 6 months, 12 months, and annually through 5 years | All-cause mortality will be assessed throughout follow-up. Results will be reported as the number and percentage of participants who die from any cause. |
| Incidence of Stroke | 30 days, 6 months, 12 months, and annually through 5 years | Stroke events will be assessed based on clinical neurological evaluation and classified according to Valve Academic Research Consortium 3 (VARC-3) definitions. Results will be reported as the number and percentage of participants experiencing stroke. |
| Incidence of Bioprosthetic Valve-Related Reintervention | 30 days, 6 months, 12 months, and annually through 5 years | Bioprosthetic valve-related reintervention will be defined as any surgical or transcatheter intervention performed to treat dysfunction or failure of the implanted study valve. Results will be reported as the number and percentage of participants undergoing valve-related reintervention. |
| Incidence of Bioprosthetic Valve Dysfunction According to VARC-3 Definitions | 30 days, 6 months, 12 months, and annually through 5 years | Bioprosthetic valve dysfunction will be assessed according to Valve Academic Research Consortium 3 (VARC-3) definitions. Bioprosthetic valve dysfunction includes structural valve deterioration, non-structural valve dysfunction, valve thrombosis, and endocarditis. Results will be reported as the number and percentage of participants meeting the criteria for bioprosthetic valve dysfunction and according to the corresponding category. |
| Incidence of Bioprosthetic Valve Failure According to VARC-3 Definitions | 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after the index procedure | Bioprosthetic valve failure will be assessed according to Valve Academic Research Consortium 3 (VARC-3) definitions. Results will be reported as the number and percentage of participants meeting the criteria for bioprosthetic valve failure. |
Contacts
CONTACTClinical Research Department - Braile Biomédica
Outcome results
None listed