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

NCT07806409 | Not Yet Recruiting

• 1 other identifier: SAFESYNC NG
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Stenosis Senile; Aortic Stenosis Symptomatic; Aortic Stenosis

Keywords

Aortic Valve Stenosis; Transcatheter Aortic Valve Implantation; TAVI; Balloon-Expandable Transcatheter Heart Valve

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days after the procedure

Secondary Outcomes (10)

• Percentage of Participants Achieving Technical Success According to VARC-3 Criteria

  During the procedure

• Incidence and Severity of Paravalvular Leak

  30 days, 6 months, 12 months, and annually through 5 years

• Mean Transvalvular Aortic Pressure Gradient Assessed

  30 days, 6 months, 12 months, and annually through 5 years

• Distribution of Participants by New York Heart Association Functional Class

  30 days, 6 months, 12 months, and annually through 5 years

• Incidence of New Permanent Pacemaker Implantation

  30 days, 6 months, 12 months, and annually through 5 years

Study Arms (1)

INOVARE® SAFESYNC Next-Generation TAVI

EXPERIMENTAL

Device: INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve

Interventions

INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve DEVICE

Participants will undergo TAVI via transfemoral access using the INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve and the B-Delivery System.

INOVARE® SAFESYNC Next-Generation TAVI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Braile Biomedica Ind. Com. e Repr. Ltda.: lead

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Clinical Research Department - Braile Biomédica

CONTACT

+5517 21367000; pesquisa@braile.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: September 8, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): June 1, 2032
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share