NCT03003299招募中不适用
A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
Edwards Lifesciences102 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2017年1月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 102
- 主要终点
- Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke
研究概览
简要总结
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
详细描述
This is a prospective, single-arm, multicenter study.
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 surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
- •Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
- •NYHA Functional Class ≥ II.
- •Heart Team agrees the patient is low to intermediate risk.
- •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.
排除标准
- •Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
- •Severe regurgitation (> 3+) or stenosis of any other valve
- •Failing valve has moderate or severe paravalvular regurgitation
- •Failing valve is unstable, rocking, or not structurally intact
- •Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
- •Increased risk of embolization of THV
- •Known bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve
- •Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
- •Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
- •Anatomical characteristics that would preclude safe access to the apex (Transapical)
- •Evidence of an acute myocardial infarction ≤ 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 or implantable cardioverter defibrillator is not considered an exclusion.
- •Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation
- •Leukopenia, anemia, thrombocytopenia, 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 interventional/surgical procedures within 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
- •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 within 90 days of enrollment
- •Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
- •Renal insufficiency and/or renal replacement therapy at the time of screening
- •Active bacterial endocarditis within 180 days of the procedure
- •Patient refuses blood products
- •Estimated life expectancy < 24 months
- •Positive urine or serum pregnancy test in female subjects of childbearing potential
- •Currently participating in an investigational drug or another device study
结局指标
主要结局
Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke
时间窗: 1 year
Number of patients that died and/or had a stroke
次要结局
- Peak gradient(30 days)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(30 days)
- Six-Minute Walk Test (6MWT)(30 days)
- Mean gradient(30 days)
- New York Heart Association (NYHA) Classification(30 days)
研究者
研究点 (102)
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