NCT06119607进行中（未招募）不适用
A Prospective, Single-arm, Exploratory Clinical Investigation to Assess Preliminary Safety and Collect Performance and Effectiveness Data of the TRIFLO Heart Valve
Novostia SA2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年11月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety - Mortality
研究概览
简要总结
A prospective, single arm, exploratory clinical investigation to assess preliminary safety and collect performance and effectiveness data of the TRIFLO Heart Valve.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Safety - Mortality
时间窗: At 12 and 18 months post procedure
Rate of occurrence of all-cause mortality, cardiovascular, non-cardiovascular, and device-related mortality
Safety - Thrombotic events
时间窗: Between 3 to 18 months post procedure
Rate of valve related thrombotic events
次要结局
- Safety - Reoperation(1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.)
- Safety - Bleeding(1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.)
- Safety - Pacemaker(3 months)
- Safety - Procedural mortality(1 month.)
- Usability(Procedure)
- Safety - Major adverse cardiovascular events(1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months)
- Safety - Atrial Fibrillation(3, 9, 12, 15, 18, 24, 36, 48 and 60 months)
- Safety - Thrombotic events(24, 36, 48 and 60 months.)
- Safety - Thromboembolism events(1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.)
- Safety - Endocarditis(1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.)
- Safety - Structural & Non structural Valve Dysfunction(1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.)
- Safety - Hemolysis(1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months.)
- Performance - Regurgitation(1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months)
- Performance - EOA(1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months)
- Effectiveness - NYHA(1, 3, 9, 12, 18, 24, 36, 48 and 60 months)
- Effectiveness - QoL(1, 3, 9, 12, 18, 24, 36, 48 and 60 months)
- Safety - All-cause mortality(1, 3, 9, 15, 24, 36, 48 and 60 months)
- Performance - Procedure(Procedure)
- Performance - Hemodynamics(1, 3, 9, 12, 15, 18, 24, 36, 48 and 60 months)
- Performance - Noise(3, 9, 12, 15, 18, 24, 36, 48 and 60 months)
- Effectiveness - 6MWT(3, 9, 12, 18, 24, 36, 48 and 60 months)
研究者
研究点 (2)
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