PILot Aortic Triflo Valve Study

Aortic Valve Disease Clinical Trial

— PILATUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119607
• Other study ID #: 100144
• Secondary ID: CIV-LT-23-08-043
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: May 2029

Study information

• Verified date: March 2024
• Source: Novostia SA
• Contact: Pomme Boissier, PhD
• Phone: 0041 58 501 30 33
• Email: p.boissier[@]novostia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2029
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Device:
• TRIFLO Heart Valve
Surgical Aortic Valve Replacement - Mechanical Valve

Locations

Country	Name	City	State
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius

Sponsors (2)

Lead Sponsor	Collaborator
Novostia SA	Veranex

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Mortality	Rate of occurrence of all-cause mortality, cardiovascular, non-cardiovascular, and device-related mortality	At 12 and 18 months post procedure
Primary	Safety - Thrombotic events	Rate of valve related thrombotic events	Between 3 to 18 months post procedure
Secondary	Safety - Major adverse cardiovascular events	Rate of occurrence of MACEs	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months
Secondary	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.
Secondary	Safety - Thrombotic events	Rate of valve-related thrombotic events	24, 36, 48 and 60 months.
Secondary	Safety - Atrial Fibrillation	Rate of occurrence of New Onset Atrial Fibrillation	3, 9, 12, 15, 18, 24, 36, 48 and 60 months
Secondary	Safety - Endocarditis	Rate of occurrence of Endocarditis	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
Secondary	Safety - Hemolysis	Rate of occurrence of Hemolysis followed by Plasma free hemoglobin	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
Secondary	Safety - Reoperation	Rate of occurrence of Reoperation	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
Secondary	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.
Secondary	Safety - Bleeding	Rate of occurrence of bleeding classified according to BARC	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
Secondary	Safety - Pacemaker	Rate of occurrence New pacemaker implantation due to intervention	3 months
Secondary	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
Secondary	Safety - Procedural mortality	Rate of occurrence of Procedural mortality	1 month.
Secondary	Performance - Procedure	Rate of initial success, correct positioning of a single TRIFLO Heart Valve into the proper anatomical location.	Procedure
Secondary	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
Secondary	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
Secondary	Performance - EOA	Change of Effective Orifice Area (EOA) compared to baseline	1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months
Secondary	Performance - Noise	Assessment of noise perception - patient survey	3, 9, 12, 15, 18, 24, 36, 48 and 60 months
Secondary	Effectiveness - NYHA	Change of NYHA Score compared to baseline	1, 3, 9, 12, 18, 24, 36, 48 and 60 months
Secondary	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
Secondary	Effectiveness - 6MWT	Functional Assessment in 6-min walk test	3, 9, 12, 18, 24, 36, 48 and 60 months
Secondary	Usability	Assessment of device handling ease by the physician - survey	Procedure