NCT03517436进行中（未招募）不适用
A Prospective, Single-arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
Edwards Lifesciences46 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2018年9月18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
- 101
- 试验地点
- 46
- 主要终点
- All-cause Death
研究概览
简要总结
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).
详细描述
A prospective, single-arm, controlled, multicenter study. Up to 2 roll-ins were allowed per site but not counted towards total enrollment.
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
- •Severe, calcific AS
- •NYHA functional class ≥ II
- •Judged by the Heart Team to be at intermediate risk for open surgical therapy
- •The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
排除标准
- •Native aortic annulus size unsuitable for sizes 23, 26 or 29 mm CENTERA THV based on 3D imaging analysis
- •Aortic valve is unicuspid, bicuspid or non-calcified
- •Pre-existing mechanical or bioprosthetic valve in any position
- •Known hypersensitivity to Nitinol (nickel or titanium)
- •Severe aortic regurgitation (> 3+)
- •Severe mitral regurgitation (> 3+) or ≥ moderate stenosis
- •Ventricular dysfunction with left ventricular ejection fraction < 30%
- •Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- •Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure
- •Subjects with planned concomitant ablation for atrial fibrillation
- •Hypertrophic cardiomyopathy with obstruction
- •Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR
- •Complex coronary artery disease
- •Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
- •Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system
- •Active bacterial endocarditis within 180 days of the valve implant procedure
- •Stroke or transient ischemic attack within 90 days of the valve implant procedure
- •Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of the valve implant procedure
- •Severe lung disease or currently on home oxygen
- •Severe pulmonary hypertension
- •Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the valve implant procedure
- •History of cirrhosis or any active liver disease
- •Renal insufficiency and/or renal replacement therapy at the time of screening
- •Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
- •Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure
- •Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
- •Significant frailty as determined by the Heart Team
- •Immobility that would prevent completion of study procedures
- •Subject refuses blood products
- •Body mass index > 50 kg/m2
- •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
All-cause Death
时间窗: 1 year
Number of participants that died
次要结局
未报告次要终点
研究者
研究点 (46)
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