Aortic Stenosis SenileSAFESYNC NGNCT07806409
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis
A study testing INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve in people with Aortic Stenosis Senile and Aortic Stenosis Symptomatic, run by Braile Biomedica Ind. Com. e Repr. Ltda..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis Senile, Aortic Stenosis Symptomatic, Aortic Stenosis
- What is being tested?
- INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jun 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve
- Keywords
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, TAVI, Balloon-Expandable Transcatheter Heart Valve
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart ValveDevice
Participants will undergo TAVI via transfemoral access using the INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve and the B-Delivery System.
| Study group | Role | What they receive |
|---|---|---|
| INOVARE® SAFESYNC Next-Generation TAVI | Experimental | Not described Receives: Device: INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after the procedure
Secondary outcomes (10)
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.
Measured: 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.
Measured: 30 days, 6 months, 12 months, and annually through 5 years
Mean Transvalvular Aortic Pressure Gradient Assessed
Mean transvalvular aortic pressure gradient will be assessed by transthoracic echocardiography and reported in mmHg.
Measured: 30 days, 6 months, 12 months, and annually through 5 years
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.
Measured: 30 days, 6 months, 12 months, and annually through 5 years
Incidence of New Permanent Pacemaker Implantation
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.
Measured: 30 days, 6 months, 12 months, and annually through 5 years
Incidence of All-Cause Mortality
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.
Measured: 30 days, 6 months, 12 months, and annually through 5 years
Incidence of Stroke
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.
Measured: 30 days, 6 months, 12 months, and annually through 5 years
Incidence of Bioprosthetic Valve-Related Reintervention
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.
Measured: 30 days, 6 months, 12 months, and annually through 5 years
Incidence of Bioprosthetic Valve Dysfunction According to VARC-3 Definitions
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.
Measured: 30 days, 6 months, 12 months, and annually through 5 years
Incidence of Bioprosthetic Valve Failure According to VARC-3 Definitions
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.
Measured: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis SenileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806409
- Sponsor's protocol ID
- SAFESYNC NG
- Acronym
- SAFESYNC NG
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No