PILot Aortic Triflo Valve Study (PILATUS)

A Prospective, Single-arm, Exploratory Clinical Investigation to Assess Preliminary Safety and Collect Performance and Effectiveness Data of the TRIFLO Heart Valve

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

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Device: TRIFLO Heart Valve

Detailed Description

Up to 10 Subjects requiring aortic valve replacement of the native valve will be included in this First in Human clinical investigation on the TRIFLO Heart Valve device in Europe. The study is prospective, single-arm-open-label-non-randomized.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santaros Klinikos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRIFLO	Device: TRIFLO Heart Valve; Surgical Aortic Valve Replacement - Mechanical Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Major adverse cardiovascular events	Rate of occurrence of MACEs	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months
Safety - Thromboembolism events	Rate of occurrence of Transient Ischemic Attack (TIA), coronary and/or peripheral embolism	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
Safety - Thrombotic events	Rate of valve-related thrombotic events	24, 36, 48 and 60 months.
Safety - Atrial Fibrillation	Rate of occurrence of New Onset Atrial Fibrillation	3, 9, 12, 15, 18, 24, 36, 48 and 60 months
Safety - Endocarditis	Rate of occurrence of Endocarditis	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
Safety - Hemolysis	Rate of occurrence of Hemolysis followed by Plasma free hemoglobin	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
Safety - Reoperation	Rate of occurrence of Reoperation	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
Safety - Structural & Non structural Valve Dysfunction	Rate of occurrence of Structural & Non structural Valve Dysfunction	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
Safety - Bleeding	Rate of occurrence of bleeding classified according to BARC	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
Safety - Pacemaker	Rate of occurrence New pacemaker implantation due to intervention	3 months
Safety - All-cause mortality	Rate of occurrence of All-cause mortality, cardiovascular, non-cardiovascular, and device related mortality	1, 3, 9, 15, 24, 36, 48 and 60 months
Safety - Procedural mortality	Rate of occurrence of Procedural mortality	1 month.
Performance - Procedure	Rate of initial success, correct positioning of a single TRIFLO Heart Valve into the proper anatomical location.	Procedure
Performance - Hemodynamics	Change of hemodynamics compared to baseline followed by mean aortic valve pressure gradient	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months
Performance - Regurgitation	Change of regurgitation class (As per VARC 3 Classification Guidelines) compared to baseline	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months
Performance - EOA	Change of Effective Orifice Area (EOA) compared to baseline	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months
Performance - Noise	Assessment of noise perception - patient survey	3, 9, 12, 15, 18, 24, 36, 48 and 60 months
Effectiveness - NYHA	Change of NYHA Score compared to baseline	1, 3, 9, 12, 18, 24, 36, 48 and 60 months
Effectiveness - QoL	Change of Quality-of-life Score using KCCQ-12 questionnaires, compared to baseline	1, 3, 9, 12, 18, 24, 36, 48 and 60 months
Effectiveness - 6MWT	Functional Assessment in 6-min walk test	3, 9, 12, 18, 24, 36, 48 and 60 months
Usability	Assessment of device handling ease by the physician - survey	Procedure

Collaborators and Investigators

• Sponsor: Novostia SA
• Collaborators: Veranex
• Investigators: Principal Investigator: Kęstutis Ručinskas, Prof., Vilnius University Hospital Santaros Clinics

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: 100144; CIV-LT-23-08-043783 (Other Identifier: VASPVT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No