Clinical trial NCT06119607: PILot Aortic Triflo Valve Study
Official title: A Prospective, Single-arm, Exploratory Clinical Investigation to Assess Preliminary Safety and Collect Performance and Effectiveness Data of the TRIFLO Heart Valve
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Valve Disease
Lead sponsor: Novostia SA
Sponsor class: INDUSTRY
Collaborators: name: Veranex
First posted: 2023-11-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, single arm, exploratory clinical investigation to assess preliminary safety and collect performance and effectiveness data of the 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety - Mortality
timeFrame: At 12 and 18 months post procedure
measure: Safety - Thrombotic events
timeFrame: Between 3 to 18 months post procedure
Secondary outcomes:
measure: Safety - Major adverse cardiovascular events
timeFrame: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months
measure: Safety - Thromboembolism events
timeFrame: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
measure: Safety - Thrombotic events
timeFrame: 24, 36, 48 and 60 months.
measure: Safety - Atrial Fibrillation
timeFrame: 3, 9, 12, 15, 18, 24, 36, 48 and 60 months
measure: Safety - Endocarditis
timeFrame: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
measure: Safety - Hemolysis
timeFrame: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
measure: Safety - Reoperation
timeFrame: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
measure: Safety - Structural & Non structural Valve Dysfunction
timeFrame: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
measure: Safety - Bleeding
timeFrame: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.
measure: Safety - Pacemaker
timeFrame: 3 months
measure: Safety - All-cause mortality
timeFrame: 1, 3, 9, 15, 24, 36, 48 and 60 months
measure: Safety - Procedural mortality
timeFrame: 1 month.
measure: Performance - Procedure
timeFrame: Procedure
measure: Performance - Hemodynamics
timeFrame: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months
measure: Performance - Regurgitation
timeFrame: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months
measure: Performance - EOA
timeFrame: 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months
measure: Performance - Noise
timeFrame: 3, 9, 12, 15, 18, 24, 36, 48 and 60 months
measure: Effectiveness - NYHA
timeFrame: 1, 3, 9, 12, 18, 24, 36, 48 and 60 months
measure: Effectiveness - QoL
timeFrame: 1, 3, 9, 12, 18, 24, 36, 48 and 60 months
measure: Effectiveness - 6MWT
timeFrame: 3, 9, 12, 18, 24, 36, 48 and 60 months
measure: Usability
timeFrame: Procedure
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
Study officials:
affiliation: Vilnius University Hospital Santaros Clinics
name: Kęstutis Ručinskas, Prof.
role: PRINCIPAL_INVESTIGATOR
References: