跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT01531374
NCT01531374已完成不适用

Medtronic CoreValve® Continued Access Study

Medtronic Cardiovascular90 个研究点 分布在 1 个国家目标入组 2,777 人开始时间: 2012年2月21日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,777
试验地点
90
主要终点
Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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 very high risk and high risk for aortic valve surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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

  • •High Risk: Subject must have co-morbidities 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.
  • •Extreme Risk: Subject must have co-morbidities 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.
  • •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 MCS TAVI procedure including bare metal and drug eluting stents.
  • •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 GI bleeding that would preclude anticoagulation.
  • •A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
  • •Heparin (HIT/HITTS) and bivalirudin
  • •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.
  • •High Risk:Native aortic annulus size < 20 mm or > 29 mm per the baseline diagnostic imaging (until 23mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort)
  • •Extreme Risk: Native aortic annulus size < 18 mm or > 29 mm per the baseline diagnostic imaging. (High risk and extreme risk upon 23mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort)
  • •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.
  • •Echocardiographic evidence of new or untreated 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 aortic 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 (Extreme Risk only until 23 mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort).
  • •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

  • Conduction Disturbance Requiring Permanent Pacemaker Implantation(30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.)
  • Change From Baseline in Distance Walked During 6-Minute Walk Test (6MWT)(Baseline to 30 days, baseline to 1 year)
  • Major Adverse Events (MAEs)(30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.)
  • Quality of Life (QoL) Change(30 day, 6 month, 1 year. The 2-5 year outcome data will be reported once data set is complete.)
  • Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)(30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.)
  • Ratio of Days Alive Out of Hospital at 365 Days Post Procedure Versus Total Days Alive(1 year)
  • Cardiovascular Deaths and Valve-Related Deaths(30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.)
  • Strokes and Transient Ischemic Attacks (TIAs)(30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.)
  • Index Procedure Related MAEs(Procedure)
  • Length of Index Procedure Hospital Stay(Number of days from admission to discharge)
  • The Occurrence of Individual MACCE Components(30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.)
  • Change From Baseline in NYHA Class(Baseline to 30 days, baseline to 6 months, baseline to 1 year. The 2-5 year outcome data will be reported once data set is complete.)
  • Aortic Valve Hospitalizations(30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.)
  • Device Success(Number of days from admission to discharge)
  • Procedural Success(Number of days from admission to discharge)
  • Prosthetic Valve Dysfunction (PVD)(30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.)
  • Echocardiographic Assessment of Valve Performance(30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.)

研究者

发起方
Medtronic Cardiovascular
申办方类型
Industry
责任方
Sponsor

研究点 (90)

Loading locations...

相似试验

已完成
不适用
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve ReplacementSevere Aortic Stenosis
NCT01240902Medtronic Cardiovascular1,453
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 Stenosis
NCT01675440Medtronic Cardiovascular782
已完成
不适用
CoreValve Advance International Post Market StudySevere Aortic Stenosis
NCT01074658Medtronic Bakken Research Center1,015
已完成
不适用
Medtronic CoreValve Evolut R U.S. Clinical StudyAortic Stenosis
NCT02207569Medtronic Cardiovascular241
已完成
不适用
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical StudyAortic Stenosis
NCT01876420Medtronic Cardiovascular60