NCT03193801进行中（未招募）不适用
PARTNER 3 Trial - SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve
Edwards Lifesciences24 个研究点 分布在 3 个国家目标入组 53 人开始时间: 2018年2月1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
- 53
- 试验地点
- 24
- 主要终点
- Safety and Effectiveness - Composite of All-cause Mortality and Stroke
研究概览
简要总结
To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
详细描述
A prospective, single-arm, multicenter clinical trial. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
- •Surgical bioprosthetic valve with a true internal diameter (True ID) of 16.5 mm to 28.5 mm.
- •NYHA Functional Class ≥ II.
- •Heart Team agrees the patient is intermediate risk (i.e. STS score of ≥3 and < 8).
- •Heart Team agrees valve implantation will likely benefit the patient.
- •The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) / Ethics Committee (EC) of the respective clinical site.
排除标准
- •Index valve has ≥ mild paravalvular regurgitation where the surgical bioprosthesis is not securely fixed in the native annulus or is not structurally intact as determined by transesophageal echocardiography (TEE).
- •Surgical or transcatheter aortic valve placed so that extension into left ventricular outflow tract (LVOT) that may impinge on the mitral implant.
- •Known residual mean gradient >10 mmHg at the end of the index procedure for implantation of the original surgical valve.
- •Severe right ventricle (RV) dysfunction.
- •Anatomical characteristics that would preclude safe access to the apex (transapical).
- •Severe regurgitation or stenosis of any other valve.
- •Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen
- •Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 systemic pressure)
- •Anatomical characteristics that would increase risk of LVOT obstruction (e.g., aortomitral angle, LVOT size, etc.).
- •Evidence of an acute myocardial infarction ≤ 1 month (30 days) before enrollment.
- •Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker (PPM) or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
- •Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation.
- •Leukopenia (white blood count < 3000 cell/mL), anemia (hemoglobin < 9 g/dL), thrombocytopenia (blood platelet count < 50,000 cell/mL), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
- •Untreated clinically significant coronary artery disease requiring revascularization.
- •Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment.
- •Emergency intervention/surgical procedures within one month (30 days) prior to the procedure.
- •Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure.
- •Hypertrophic cardiomyopathy with obstruction (HOCM).
- •Left ventricular ejection fraction (LVEF) < 30%.
- •Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.
- •Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure.
- •Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication.
- •Stroke or transient ischemic attack (TIA) within 90 days of enrollment.
- •Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment.
- •Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy at the time of screening.
- •Active bacterial endocarditis within 6 months (180 days) of the procedure.
- •Patient refuses blood products.
- •Estimated life expectancy < 24 months.
- •Currently participating in an investigational drug or another device study. Note: Clinical trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- •Positive urine or serum pregnancy test in female subjects of childbearing potential.
结局指标
主要结局
Safety and Effectiveness - Composite of All-cause Mortality and Stroke
时间窗: 1 Year
Non-hierarchical composite endpoint of all-cause mortality and stroke at 1-year post-procedure
次要结局
- Mitral Regurgitation - Change From Baseline(30 days)
- New York Heart Association (NYHA) Functional Class - Change From Baseline(30 Days)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) - Change From Baseline(30 days)
- Pulmonary Artery Systolic Pressure - Change From Baseline(30 days)
研究者
研究点 (24)
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