An interventional study of INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve in Aortic Stenosis Senile, Aortic Stenosis Symptomatic and Aortic Stenosis, sponsored by Braile Biomedica Ind. Com. e Repr. Ltda.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Braile Biomedica Ind. Com. e Repr. Ltda. · Not applicable, Interventional, and Treatment
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.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 40 is below the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Braile Biomedica Ind. Com. e Repr. Ltda. is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: INOVARE® 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months after the index procedure
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jul 2027, 8 months later.
Of 111 industry-sponsored interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 54. This study's planned 8 months is below that.
Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Braile Biomedica Ind. Com. e Repr. Ltda.