Medtronic Evolut™ EXPAND TAVR I Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 14
- 主要终点
- Acute Kidney Injury
研究概览
简要总结
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
详细描述
Single-arm, descriptive, multi-center, international
All subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm^2, or aortic valve area index ≤ 0.6 cm^2/m^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec
- •Subject denies symptoms attributable to aortic stenosis, including but not limited to:
- •Dyspnea on rest or exertion
- •Syncope in the absence of another identifiable cause
- •Left Ventricular Ejection Fraction (LVEF) >50%
排除标准
- •Age <65 years
- •Class I indication for cardiac surgery
- •Bicuspid, unicuspid, or quadricuspid aortic valve
- •In need of and suitable for coronary revascularization
结局指标
主要结局
Acute Kidney Injury
时间窗: 6 months
Rate of acute kidney injury
New-onset Atrial Fibrillation
时间窗: 6 months
Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)
Cardiovascular and Heart Failure Hospitalizations
时间窗: 6 months
Rate of cardiovascular and heart failure hospitalizations
Heart Failure Events
时间窗: 6 months
Rate of heart failure events
Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography
时间窗: 6 months
Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography
时间窗: 6 months
Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.
Major Vascular Complications
时间窗: 6 months
Rate of major vascular complications
All-cause and Cardiovascular Mortality
时间窗: 6 months
Rate of all-cause and cardiovascular mortality
Valve-related Dysfunction Requiring Repeat Procedure
时间窗: 6 months
Rate of valve-related dysfunction requiring repeat procedure
All Stroke (Disabling and Non-disabling)
时间窗: 6 months
Rate of disabling and non-disabling stroke
Myocardial Infarction (Periprocedural and Spontaneous)
时间窗: 6 months
Rate of periprocedural and spontaneous myocardial infarction
Life-threatening Bleed
时间窗: 6 months
Rate of life-threatening (or disabling) bleed
New Permanent Pacemaker Implantation (PPI)
时间窗: 6 months
Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)
New Intraventricular Conduction Delays
时间窗: 6 months
Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)
Change From Baseline in Global Longitudinal Strain (GLS)
时间窗: 6 months
Reporting of change in GLS from baseline by echocardiography
Device Success (VARC-2)
时间窗: Discharge (12 hours to 7 days post-procedure)
The VARC-2 definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity \<3 m/sec), and absence of moderate or severe prosthetic valve regurgitation
Change From Baseline in New York Heart Association (NYHA) Functional Classification
时间窗: 30 days and 6 months
Reporting of NYHA classification change from baseline to 30 days and 6 months NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Change From Baseline in Six-minute Walk Test (6MWT)
时间窗: 6 months
Reporting change from baseline in distance walked during 6MWT
Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography
时间窗: 6 months
Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography
Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography
时间窗: 6 months
Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography
Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
时间窗: 30 days and 6 months
KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
时间窗: 6 months
Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography
Change From Baseline in Left Ventricular Filling Pressure (E:e')
时间窗: 6 months
Reporting of change in left ventricular filling pressure (E:e') from baseline by echocardiography
Change From Baseline in Stroke Volume Index (SVI)
时间窗: 6 months
Reporting of change in stroke volume index (SVI) from baseline by echocardiography
Change From Baseline in NT-pro B-type Natriuretic Peptide (NT-proBNP)
时间窗: 6 months
Reporting of change in NT-pro B-type natriuretic peptide (NT-proBNP) from baseline
次要结局
未报告次要终点