NCT01586910进行中（未招募）不适用
Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)
Medtronic Cardiovascular167 个研究点 分布在 5 个国家目标入组 1,746 人开始时间: 2012年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,746
- 试验地点
- 167
- 主要终点
- All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability
研究概览
简要总结
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.
Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subject must have co-morbidities such that Heart Team agrees predicted risk of operative mortality is ≥3% and <15% at 30 days (Intermediate Clinical Risk classification). Heart team evaluation of clinical surgical mortality risk for each patient includes the calculated STS score for predicted risk of surgical mortality augmented by consideration of the overall clinical status and co-morbidities unmeasured by the STS risk calculation;
- •Heart Team unanimously agree on treatment proposal and eligibility for randomization* based on their clinical judgement (including anatomy assessment, risk factors, etc.);
- •Subject has severe aortic stenosis presenting with;
- •Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index < 0.6cm2/m2 AND
- •Mean gradient > 40mmHg or Vmax > 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization [or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) <55%] or velocity ratio < 0.25;
- •Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
- •Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
- •Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;
排除标准
- •Subject has refused surgical aortic valve replacement (SAVR) as a treatment option; (not applicable for Single Arm)
- •Any condition considered a contraindication for placement of a bioprosthetic valve (i.e., subject requires a mechanical valve);
- •A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
- •Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
- •Ongoing sepsis, including active endocarditis;
- •Any condition considered a contraindication to extracorporeal assistance;
- •Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization* (Subjects with recent placement of drug eluting stent(s) should be assessed for ability to safely proceed with SAVR within the protocol timeframe);
- •Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization*;
- •Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
- •Recent (within 6 months of randomization*) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
- •Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
- •Subject refuses a blood transfusion;
- •Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
- •Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery (Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned);
- •Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid 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-up exams;
- •Currently participating in an investigational drug or another device trial (excluding registries);
- •Evidence of an acute myocardial infarction ≤30 days before the index procedure;
- •Need for emergency surgery for any reason;
- •True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);
- •Extensive mediastinal radiation;
- •Liver failure (Child-C);
- •Reduced ventricular function with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram;
- •Uncontrolled atrial fibrillation (e.g. resting heart rate > 120 bpm);
- •Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
- •End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min;
- •Pulmonary Hypertension (systolic pressure> 80mmHg);
- •Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc;
- •Frailty assessments identify:
- •Subject is < 80 years of age and three or more of the following apply
- •Subject is ≥ 80 years of age and two or more of the following apply
- •Wheelchair bound
- •Resides in an institutional care facility (e.g., nursing home, skilled care center)
- •Body Mass Index < 20 kg/m2
- •Grip Strength < 16 kg
- •Katz Index Score ≤ 4
- •Albumin < 3.5 g/dL;
- •Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention; (Not applicable for Single Arm)
- •Note: Additional anatomical and vascular exclusion criteria may apply.
- •Note: * For purposes of the single arm phase of the trial, "randomization" will refer to trial enrollment.
研究组 & 干预措施
SAVR
Active Comparator
Surgical Aortic Valve Replacement (SAVR)
干预措施: Surgical Aortic Valve Replacement (SAVR) (Procedure)
Medtronic CoreValve® System TAVI
Experimental
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
干预措施: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI) (Device)
Medtronic CoreValve® System TAVI
Experimental
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
干预措施: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) (Device)
结局指标
主要结局
All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability
时间窗: 24 months
All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline.
次要结局
- Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Percentage of Participants With Individual MACCE Components(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Percentage of Participants With Major Adverse Events (MAE)(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation(30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Change in Distance Walked During 6-minute Walk Test (6MWT)(From baseline to 30 days, baseline to 12 months, and baseline to 24 months)
- Ratio of Days Alive Out of Hospital Versus Total Days Alive(12 and 24 months)
- Quality of Life (QoL) Change From Baseline(Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only)(6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Percentage of Participants With Early Safety Endpoint(30 Days)
- Percentage of Participants With Clinical Efficacy (After 30 Days)(6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete)
- Percentage of Participants With Time-Related Safety(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available.)
- Resheath and Recapture Success (Evolut R Only)(Procedure)
- Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Percentage of Participants With Individual MACCE Components(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Percentage of Participants With Major Adverse Events (MAE)(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation(30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Change in Distance Walked During 6-minute Walk Test (6MWT)(From baseline to 30 days, baseline to 12 months, and baseline to 24 months)
- Ratio of Days Alive Out of Hospital Versus Total Days Alive(12 and 24 months)
- Quality of Life (QoL) Change From Baseline(Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Change in NYHA Class From Baseline(Baseline to 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance(discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete)
- Effective Orifice Area as an Assessment of Prosthetic Valve Performance(discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete)
- Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance(discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete)
- Percentage of Participants With Aortic Valve Disease Related Hospitalizations(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete)
- Percentage of Participants With Stroke and TIAs(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Peri-procedural Neurological Injury(discharge or 7 days post index procedure (whichever occurred first))
- Index Procedure Related Major Adverse Events (MAEs)(Procedure through 30 day visit)
- Length of Index Procedure Hospital Stay(Number of days from admission to discharge (expected average of 7 days))
- Presence of Atrial Fibrillation(post-procedure, discharge, 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Device Success (Medtronic CoreValve® System Subjects Only)(Number of days from admission to discharge (expected average of 7 days))
- Procedural Success (Medtronic CoreValve® System Subjects Only)(Number of days from admission to discharge (expected average of 7 days))
- Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only)(6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.)
- Percentage of Participants With Early Safety Endpoint(30 Days)
- Percentage of Participants With Clinical Efficacy (After 30 Days)(6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete)
- Percentage of Participants With Time-Related Safety(30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available.)
- Resheath and Recapture Success (Evolut R Only)(Procedure)
研究者
研究点 (167)
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