Medtronic CoreValve Evolut R United States IDE Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 241
- 试验地点
- 43
- 主要终点
- Percentage of Patients With Disabling Stroke at 30 Days
研究概览
简要总结
The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.
详细描述
This objective will be accomplished by a prospective, single arm, historical controlled, multi-site study involving a minimum of 150 implanted subjects with no more than 250 implanted subjects at up to 25 study sites in the United States. Procedural and 30 day safety and efficacy results from this study will be compared to appropriate historical control data for the Medtronic CoreValve System. Subjects will be followed up to 5 years following implantation.
The enrollment phase of the study is estimated to take approximately 6-9 months. As each implanted subject is to be followed up to 5 years, the estimated study duration is approximately 66-69 months, excluding the time required for preparing the final report.
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 aortic stenosis, defined as aortic valve area of < 1.0 cm2 (or aortic valve area index of < 0.6 cm2/m2) by the continuity equation, AND mean gradient > 40 mmHg or maximal aortic valve velocity > 4.0 m/sec by resting echocardiogram.
- •Subjects with low-flow/low gradient severe aortic stenosis can be included, provided low-dose dobutamine or exercise stress echocardiography demonstrates a mean gradient of >40 mmHg or a maximal aortic valve velocity of >4.0 m/sec, AND aortic valve area of <1.0cm2 (or aortic valve area index of <0.6 cm2/m2).
- •STS score of ≥ 8 OR documented heart team agreement of ≥ high risk for AVR due to frailty or co-morbidities.
- •Symptoms of aortic stenosis, AND NYHA Functional Class II or greater
- •The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
排除标准
- •Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).
- •A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin or heparin (HIT/HITTS) and bivalirudin, ticlopidine and clopidogrel, Nitinol (titanium or nickel), contrast media
- •Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
- •Untreated clinically significant coronary artery disease requiring revascularization.
- •Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
- •End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
- •Ongoing sepsis, including active endocarditis.
- •Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to the study procedure.
- •Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
- •Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
- •Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
- •Gastrointestinal (GI) bleeding that would preclude anticoagulation.
- •Subject refuses a blood transfusion.
- •Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
- •Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.
- •Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-ups exams.
- •Currently participating in an investigational drug or another device study (excluding registries).
- •Evidence of an acute myocardial infarction ≤ 30 days before the study procedure.
- •Need for emergency surgery for any reason.
- •Liver failure (Child-Pugh class C).
- •Subject is pregnant or breast feeding.
- •Anatomical exclusion criteria:
- •Pre-existing prosthetic heart valve in any position.
- •Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation).
- •Severe mitral regurgitation.
- •Severe tricuspid regurgitation.
- •Moderate or severe mitral stenosis.
- •Hypertrophic obstructive cardiomyopathy.
- •Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation.
- •Congenital bicuspid or unicuspid valve verified by echocardiography.
- •For transfemoral or transaxillary (subclavian) acess:
- •Access vessel diameter <5.0mm or <6.0mm for patent LIMA
结局指标
主要结局
Percentage of Patients With Disabling Stroke at 30 Days
时间窗: Assessed at 30 days post-implantation
Stroke Diagnostic Criteria: \> Acute episode of focal or global neurological deficit with at least 2 of the following: * change in level of consciousness \> * hemiplegia, hemiparesis * numbness or sensory loss affecting 1 side \> * dysphasia or aphasia * hemianopia * amaurosis fugax \> * other neurological signs or symptoms consistent with stroke 2.) No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist 3.) Confirmation of the diagnosis by at least 1 of the following: * Neurological specialist \> * Neuroimaging procedure, or on clincial grounds alone \> Stroke: durations of neural deficit \> 24 h if available neuroimaging documents a new hemofrrhage or infarct; or the neurological deficit results in death Defined by VARC II: \> An mRS (Modified Rankin Score) of 2 or more at 90 days and an increase in at least 1 mRS category from pre-stroke baseline
All-cause Mortality at 30 Days by Percent
时间窗: Assessed at 30 days post-implantation
Percentage of patients that died by any cause at 30 days
Percent Device Success Rate Between 24 and 7 Day
时间窗: Assessed at 24 hours to seven days post implantation
Percentage of patients with Device Success defined as: * Absence of procedural mortality, AND * Correct positioning of a single Evolut R valve into the proper anatomical location, AND * Absence of patient-prosthesis mismatch, and mean gradient , 20 mm Hg (or peak velocity \< 3m/sec, AND * Absence of moderate or severe prosthetic valve regurgitation
Percentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days)
时间窗: Assessed at 24 hours to 7 days post implantation
Percentage of patience with none, trace or mild total prosthetic regurgitation at early post procedure echo cardiogram (24 hours to 7 days) as evaluated by echo core lab.
次要结局
- Coronary Artery Obstruction Requiring Intervention.(Assessed at 30 days post-implantation)
- Hemodynamic Performance - Aortic Valve Area(Assessed at baseline, 30 days, 6 months, and 1 year)
- Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe(Assessed at 30 days, 6 months, and 1 year)
- Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR)(Assessed at 30 days post-implantation)
- Percent VARC II Combined Safety Endpoint at 30 Days(Assessed at 30 days post-implantation)
- Percent of Patients With Acute Kidney Injury: Stage 2 or 3 (Including Renal Replacement Therapy).(Assessed at 30 days post-implantation)
- Percent Rate of Patients Who Received New Permanent Pacemaker Implant at 30 Days(Assessed at 30 days)
- Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate(Assessed at 30 days post-implantation)
- Percent Resheath and Recapture Success Rate(Assessed intra-procedurally)
- Hemodynamic Performance -Mean Gradient(Assessed at baseline, 30 days, 6 months, and 1 year)
- Major Vascular Complication(Assessed at 30 days post-implantation)