VANTAGE Clinical Trial Evaluation of TAVR Using the NAVITOR Valve in a Global Investigation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 434
- 试验地点
- 65
- 主要终点
- The proportion of subjects who have moderate or greater paravalvular leak at 30 days (Primary Effectiveness Endpoint)
研究概览
简要总结
Evaluation of TAVR using the NAVITOR valve in a Global Investigation.
详细描述
The VANTAGE clinical trial will evaluate the safety and effectiveness of the Navitor valve in patients with severe, symptomatic aortic stenosis who are at intermediate or low risk of surgical mortality. This trial will also evaluate the safety and effectiveness of the Navitor valve in a valve-in-valve application.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who is judged by a Heart Team, including a cardiac surgeon, to be appropriate for transcatheter heart valve intervention therapy, and is deemed to be at intermediate or low risk for open surgical aortic valve replacement (i.e., heart team estimates risk of surgical mortality < 7% at 30 days, considering the Society of Thoracic Surgeons (STS) risk score, overall clinical status, and other clinical co-morbidities unmeasured by the risk calculator). *
- •New York Heart Association (NYHA) Functional Classification of II, III, or IV *
- •Degenerative aortic valve stenosis with echo-derived criteria, defined as:
- •aortic valve area (AVA) of ≤ 1.0 cm2 (or indexed EOA ≤ 0.6 cm2/m2) AND either mean gradient ≥ 40 mmHg or peak jet velocity ≥ 4.0 m/s or doppler velocity index (DVI) ≤ 0.
- •The echocardiogram supporting the qualifying AVA baseline measurement must be performed within 90 days prior to informed consent). *
- •Aortic annulus diameter of 19-30 mm and ascending aorta diameter of 26-44 mm for the specified valve size listed in the IFU, as measured by CT (systolic phase) conducted within 12 months prior to informed consent.
排除标准
- •Life expectancy is less than 2 years in the opinion of the Investigator.
- •Evidence of an acute myocardial infarction [defined as ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) with acute ischemia symptoms and troponin elevation] within 30 days prior to index procedure.
- •Untreated clinically significant coronary artery disease requiring revascularization.
- •Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior (except pacemaker or implantable cardioverter defibrillator (ICD) implant) to index procedure or planned within 30 days following the index procedure.
- •Blood dyscrasias as defined: leukopenia (WBC < 3000 mm3), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count < 50,000 cells/mm³); history of bleeding diathesis or coagulopathy
- •Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
- •Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
- •Renal insufficiency (creatinine > 3.0 mg/dL or eGFR < 30 ml/min/1.73m2) and/ or end stage renal disease requiring chronic dialysis
- •Hostile chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk (i.e., mediastinitis, radiation damage, abnormal chest wall, porcelain aorta, adhesion of aorta or internal mammary artery to sternum, etc.) *
- •Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk *
- •Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+) *
- •Aortic valve is a congenital unicuspid or congenital bicuspid valve as verified by echocardiography or CT *
- •Severe ventricular dysfunction with LVEF < 30% as measured by resting echocardiogram
- •Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position * (Note: Subjects with a bioprosthetic aortic valve may be included in the ViV cohort.)
- •Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT) *
- •Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosis with pulmonary compromise
- •Minimum access vessel diameter of < 5.0 mm for small FlexNav Delivery System and < 5.5 mm for large FlexNav Delivery System
- •Eccentricity ratio of the annulus < 0.73
- •Criterion not applicable for valve-in-valve application
研究组 & 干预措施
Primary Analysis Cohort
Navitor Transcatheter Aortic Valve System Navitor valves (23mm, 25mm, 27mm, 29mm, and 35mm Titan valve), FlexNav Delivery system (small and large) and Navitor Loading System (small, large, and LG+)
干预措施: Navitor Transcatheter Aortic valve and FlexNav Delivery system (Device)
结局指标
主要结局
The proportion of subjects who have moderate or greater paravalvular leak at 30 days (Primary Effectiveness Endpoint)
时间窗: 30 days post index procedure
Moderate or greater paravalvular leak at 30 days
Incidence of a composite of all-cause mortality or fatal stroke/stroke with disability at 12 months (Primary Safety Endpoint)
时间窗: 12 months post index procedure
A composite of all-cause mortality or fatal stroke/stroke with disability at 12 months post index Navitor implantation procedure per the Valve Academic Research Consortium (VARC) 3 event definitions
Primary Effectiveness Endpoint: Percentage of Participants With Moderate or Greater Paravalvular Leak (PVL)
时间窗: at 30 Days
The primary effectiveness endpoint is moderate or greater paravalvular leak (PVL) at 30 days, as assessed by the echocardiographic core laboratory. The hypothesis test was performed based on the implanted population in whom a functional Navitor valve remained implanted at 30 days.
Primary Safety Endpoint: The Rates of All-cause Mortality or Fatal Stroke/Stroke With Disability
时间窗: at 12 months
The composite of rate of all-cause mortality or fatal stroke/stroke with disability at 12 months post index Navitor implantation procedure as adjudicated by the CEC per Valve Academic Research Consortium (VARC-3) definitions calculated against the performance goal of 11.3%.
次要结局
- Transvalvular gradient(12 months post index procedure)
- Effective orifice area(12 months post index procedure)
- KCCQ quality of life score(12 months post index procedure)
- Mean Change in Mean Transvalvular Gradient(Baseline to 12 months)
- Mean Change in Effective Orifice Area (EOA)(Baseline to12 months)
- Mean Change In KCCQ Quality Of Life Score(Baseline to 12 months)