PILot Aortic Triflo Valve Study

Launched by NOVOSTIA SA · Nov 6, 2023

Keywords

ClinConnect Summary

The PILot Aortic Triflo Valve Study is a clinical trial looking at a new heart valve called the TRIFLO Heart Valve, specifically for patients with aortic valve disease. This condition can cause problems with blood flow in the heart, and the trial aims to gather information on how safe and effective this new valve is for people who need to have their damaged aortic valve replaced. The study is currently active but not recruiting new participants.

To be eligible for this trial, patients must be between 18 and 75 years old and have symptoms related to aortic valve disease, such as narrowing or leaking of the valve. They should be deemed at low risk for surgery and must have certain heart function measurements that show they can safely undergo the procedure. Participants will need to take low-dose aspirin after the surgery and return for follow-up visits for up to five years. It’s important to note that there are specific health conditions that could exclude someone from participating, such as having a history of certain heart issues or being on long-term blood thinners. Overall, this study is an opportunity for eligible patients to help advance treatment options for aortic valve disease.

Gender

ALL

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.