NCT01240902已完成不适用
Medtronic CoreValve® U.S. Pivotal Trial
Medtronic Cardiovascular87 个研究点 分布在 1 个国家目标入组 1,453 人开始时间: 2010年12月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,453
- 试验地点
- 87
- 主要终点
- Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.
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
- •Extreme Risk Only: Subject must have comorbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days.
- •High Risk Surgical Only: Subject must have comorbidities such that one cardiologist and two cardiac surgeons agree that predicted risk of operative mortality is ≥15% (and predicted operative mortality or serious, irreversible morbidity risk of < 50%) at 30 days.
- •Subject has senile degenerative aortic valve stenosis with: mean gradient > 40 mmHg, or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization
- •Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.
- •The subject or the subject's legal representative has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site.
- •The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
排除标准
- •Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
- •Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the intended treatment. (High Risk Surgical Only: Including bare metal stents. Additionally, any drug eluting stents placed within 6 months prior to the index procedure.)
- •Blood dyscrasias as defined: leukopenia (WBC < 1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
- •Untreated clinically significant coronary artery disease requiring revascularization.
- •Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
- •Need for emergency surgery for any reason.
- •Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% as measured by resting echocardiogram.
- •Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
- •End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
- •Active Gastrointestinal (GI) bleeding within the past 3 months.
- •A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
- •Heparin (HIT/HITTS)
- •Bivalirudin (Extreme Risk Only)
- •Nitinol (titanium or nickel)
- •Ticlopidine and clopidogrel
- •Contrast media
- •Ongoing sepsis, including active endocarditis.
- •Subject refuses a blood transfusion.
- •Life expectancy < 12 months due to associated non-cardiac co-morbid conditions.
- •Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
- •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).
- •Currently participating in an investigational drug or another device trial.
- •Symptomatic carotid or vertebral artery disease.
- •Subject has been offered surgical aortic valve replacement but declined. (High Risk Surgical Only)
- •Native aortic annulus size < 18 mm or > 29 mm per the baseline diagnostic imaging.
- •Pre-existing prosthetic heart valve any position.
- •Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation (3-4+)).
- •Moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation.
- •Moderate to severe mitral stenosis.
- •Hypertrophic obstructive cardiomyopathy.
- •New or untreated echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- •Severe basal septal hypertrophy with an outflow gradient.
- •Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) > 70° (for femoral and left subclavian/axillary access) and > 30° (for right subclavian/axillary access).
- •Ascending aorta diameter > 43 mm if the aortic annulus diameter is 23-29 mm; ascending aorta diameter > 40 mm if the aortic annulus diameter is 20-23 mm; or an ascending aorta diameter > 34 mm if the aortic annulus diameter is 18-20 mm.
- •Congenital bicuspid or unicuspid valve verified by echocardiography.
- •Sinus of valsalva anatomy that would prevent adequate coronary perfusion.
- •- Transarterial access not able to accommodate an 18Fr sheath.
结局指标
主要结局
Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality
时间窗: 1 year
All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)
次要结局
- Ratio of Days Alive Out of Hospital Versus Total Days Alive(1 year)
- Cardiovascular Deaths and Valve Related Deaths(30 day, 6 month, 1 year, 2 year)
- Procedural Success(Number of days from admission to discharge)
- The Occurrence of Individual MACCE Components(30 day, 6 month, 1 year, 2 year)
- Change in NYHA Class(30 day, 6 month, 1 year, 2 year)
- Strokes and Transient Ischemic Attacks (TIAs)(30 day, 6 month, 1 year, 2 year)
- Index Procedure Related MAEs(Procedure)
- Aortic Valve Hospitalizations(30 day, 6 month, 1 year, 2 year)
- Device Success(Number of days from admission to discharge)
- Change in Distance Walked During 6-Minute Walk Test (6MWT)(30 day, 1 year)
- Major Adverse Events (MAEs)(30 day, 6 month, 1 year, 2 year)
- Length of Index Procedure Hospital Stay(Number of days from admission to discharge)
- Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)(30 day, 6 month, 1 year, 2 year)
- Conduction Disturbance Requiring Permanent Pacemaker Implantation(30 day, 6 month, 1 year, 2 year)
- Quality of Life (QoL) Change(30 day, 6 month, 1 year, 2 year)
- Prosthetic Valve Dysfunction (PVD)(30 day, 6 month, 1 year, 2 year)
- Echocardiographic Assessment of Valve Performance(30 day, 6 month, 1 year, 2 year)
研究者
研究点 (87)
Loading locations...
相似试验
已完成
不适用
Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve ReplacementSevere Aortic StenosisNCT01675440Medtronic Cardiovascular782
已完成
不适用
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve ReplacementSevere Aortic StenosisNCT01531374Medtronic Cardiovascular2,777
已完成
不适用
Medtronic CoreValve Evolut R U.S. Clinical StudyAortic StenosisNCT02207569Medtronic Cardiovascular241
已完成
不适用
CoreValve Advance International Post Market StudySevere Aortic StenosisNCT01074658Medtronic Bakken Research Center1,015
已完成
不适用
Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum)Aortic Valve StenosisNCT02746809Medtronic Cardiovascular72