Aortic Valve Disease
Conditions
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.
Interventions
DEVICETRIFLO Heart Valve
Surgical Aortic Valve Replacement - Mechanical Valve
Sponsors
Veranex
Novostia SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Mortality | At 12 and 18 months post procedure | Rate of occurrence of all-cause mortality, cardiovascular, non-cardiovascular, and device-related mortality |
| Safety - Thrombotic events | Between 3 to 18 months post procedure | Rate of valve related thrombotic events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Thrombotic events | 24, 36, 48 and 60 months. | Rate of valve-related thrombotic events |
| Safety - Atrial Fibrillation | 3, 9, 12, 15, 18, 24, 36, 48 and 60 months | Rate of occurrence of New Onset Atrial Fibrillation |
| Safety - Endocarditis | 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months. | Rate of occurrence of Endocarditis |
| Safety - Hemolysis | 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months. | Rate of occurrence of Hemolysis followed by Plasma free hemoglobin |
| Safety - Reoperation | 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months. | Rate of occurrence of Reoperation |
| Safety - Structural & Non structural Valve Dysfunction | 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months. | Rate of occurrence of Structural & Non structural Valve Dysfunction |
| Safety - Bleeding | 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months. | Rate of occurrence of bleeding classified according to BARC |
| Safety - Pacemaker | 3 months | Rate of occurrence New pacemaker implantation due to intervention |
| Safety - All-cause mortality | 1, 3, 9, 15, 24, 36, 48 and 60 months | Rate of occurrence of All-cause mortality, cardiovascular, non-cardiovascular, and device related mortality |
| Safety - Major adverse cardiovascular events | 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months | Rate of occurrence of MACEs |
| Performance - Procedure | Procedure | Rate of initial success, correct positioning of a single TRIFLO Heart Valve into the proper anatomical location. |
| Performance - Hemodynamics | 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months | Change of hemodynamics compared to baseline followed by mean aortic valve pressure gradient |
| Performance - Regurgitation | 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months | Change of regurgitation class (As per VARC 3 Classification Guidelines) compared to baseline |
| Performance - EOA | 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months | Change of Effective Orifice Area (EOA) compared to baseline |
| Performance - Noise | 3, 9, 12, 15, 18, 24, 36, 48 and 60 months | Assessment of noise perception - patient survey |
| Effectiveness - NYHA | 1, 3, 9, 12, 18, 24, 36, 48 and 60 months | Change of NYHA Score compared to baseline |
| Effectiveness - QoL | 1, 3, 9, 12, 18, 24, 36, 48 and 60 months | Change of Quality-of-life Score using KCCQ-12 questionnaires, compared to baseline |
| Effectiveness - 6MWT | 3, 9, 12, 18, 24, 36, 48 and 60 months | Functional Assessment in 6-min walk test |
| Usability | Procedure | Assessment of device handling ease by the physician - survey |
| Safety - Procedural mortality | 1 month. | Rate of occurrence of Procedural mortality |
| Safety - Thromboembolism events | 1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months. | Rate of occurrence of Transient Ischemic Attack (TIA), coronary and/or peripheral embolism |
Countries
Lithuania
Outcome results
None listed