PILot Aortic Triflo Valve Study

NCT06119607 | Active Not Recruiting DMC

• 2 other identifiers: 100144CIV-LT-23-08-043783
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, single arm, exploratory clinical investigation to assess preliminary safety and collect performance and effectiveness data of the TRIFLO Heart Valve.

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (2)

• Safety - Mortality

  Rate of occurrence of all-cause mortality, cardiovascular, non-cardiovascular, and device-related mortality

  At 12 and 18 months post procedure

• Safety - Thrombotic events

  Rate of valve related thrombotic events

  Between 3 to 18 months post procedure

Secondary Outcomes (21)

• Safety - Major adverse cardiovascular events

  1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months

• Safety - Thromboembolism events

  1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.

• Safety - Thrombotic events

  24, 36, 48 and 60 months.

• Safety - Atrial Fibrillation

  3, 9, 12, 15, 18, 24, 36, 48 and 60 months

• Safety - Endocarditis

  1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.

Study Arms (1)

TRIFLO

EXPERIMENTAL

Device: TRIFLO Heart Valve

Interventions

TRIFLO Heart Valve DEVICE

Surgical Aortic Valve Replacement - Mechanical Valve

TRIFLO

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is between 18 and 75 years old.
• Patient with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement with a mechanical valve is recommended according to the decision of the site heart team and validated by the independent clinical review committee.
• Patient with a low surgical mortality risk with EuroSCORE II \< 4%.
• Patient with echocardiographic Left Ventricular Ejection Fraction (LVEF) \> 35% using Transthoracic Echocardiogram (TTE).
• Assessment using echocardiography imaging modality of annular suitable for a valve of 21 mm in size and acceptable for the Body Surface Area (BSA) of the patient to avoid any patient prosthesis mismatch.
• Participants are able to take low-dose aspirin at a dose of 75 -100 mg daily or have a documented contraindication to aspirin use.
• Patient is geographically stable and willing to return to implanting site for follow-up visits up to 5 years.
• Patient has been adequately informed of risks and requirements of the clinical investigation and is willing and able to provide informed consent for participation.
• In opinion of the Investigator, the patient has a life expectancy of at least 5 years.

You may not qualify if:

• Patient has a pre-existing prosthetic valve (including TAVI) or annuloplasty device or requires replacement or repair of the mitral, pulmonary or tricuspid valve.
• Patient is maintained on any permanent or long-term anticoagulant therapy (i.e. any A-fib, deep vein thrombosis, lung embolism, percutaneous coronary intervention (PCI), previous ST-elevation myocardial infarct (STEMI)).
• Patient has a history of vascular-related neurological events (TIA, stroke, intracranial bleeding) occurring within 6 months prior to enrollment.
• Patient has active endocarditis/myocarditis or other systemic infection within 3 months of the scheduled surgery.
• Patient has an additional cardiovascular pathology which would increase surgical risk of morbidity or mortality.
• Patient is planning another unrelated surgical procedure outside of the cardiac area within the next 12 months of study device implantation.
• Patient has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg/dL or end stage renal disease requiring chronic dialysis at screening visit.
• Patient presents hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery.
• Patient has active, clinically relevant bleeding disorder (documented leukopenia (WBC \< 4.0 x 103/μL), acute anemia (Hgb \< 10.0 g/dL or 6 mmol/L), thrombocytopenia (platelet count \< 100 x 103/μL) or history of bleeding diathesis or coagulopathy).
• Patient has had prior organ transplant or is currently an organ transplant candidate.
• Patient is currently participating or participated in the last 30 days in another investigational device or drug trial.
• Patient who is pregnant, plan to become pregnant during the time of the clinical trial or is lactating or patient of childbearing age not taking any effective method of birth control.
• Patient is considered part of vulnerable population (i.e. prison inmates).
• Patient with documented history of substance (drug or alcohol) abuse within the last 5 years prior to implantation procedure.

Sponsors & Collaborators

• Novostia SA: lead
• Veranex: collaborator

Study Sites (1)

Vilnius University Hospital Santaros Klinikos

Vilnius, Vilnius County, LT-08661, Lithuania

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Kęstutis Ručinskas, Prof.

  Vilnius University Hospital Santaros Clinics

  PRINCIPAL INVESTIGATOR

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: October 31, 2023
• First Posted: November 7, 2023
• Study Start: November 30, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)