Cerebral Protection in Transcatheter Aortic Valve Replacement - The SENTINEL Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 363
- 试验地点
- 16
- 主要终点
- Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure.
研究概览
简要总结
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior circulation.
详细描述
The Sentinel™ Cerebral Protection System is indicated for use as an embolic capture and retrieval system intended to reduce the ischemic burden in the cerebral anterior circulation while performing transcatheter aortic valve replacement.
The objective of this study is to assess the safety and efficacy of the Claret Medical Sentinel Cerebral Protection System used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR) compared to TAVR standard of care (without embolic protection).
The study population is comprised of subjects with severe symptomatic calcified native aortic valve stenosis who meet the commercially approved indications for TAVR with the Edwards SAPIEN THV or SAPIEN XT and comply with the inclusion/exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Approved indications for commercially available Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX or SAPIEN XT, model 9300TFX meeting one of the three sub-criteria below:
- •transfemoral delivery in subjects with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction >20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to either be:
- •inoperable and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis; or
- •be operative candidates for aortic valve replacement but who have a Society of Thoracic Surgeons predicted operative risk score >8% or are judged by the heart team to be at a 15% risk of mortality for surgical aortic valve replacement.
- •transapical delivery in subjects with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction > 20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to be operative candidates for aortic valve replacement but who have a Society of Thoracic Surgeons operative risk score 8% or are judged by the heart team to be at a 15% risk of mortality for surgical aortic valve replacement.
- •SAPIEN XT (Transfemoral or Transapical only)
- •in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient of ≥ 40 mmHg, or a peak aortic-jet velocity of ≥ 4.0 m/s), and with native anatomy appropriate for the 23, 26, or 29 mm valve system, who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).
- •Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (> 70%) as determined by Multi-Slice Computed Tomography (MSCT) scan or equivalent imaging modality
- •The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visit
- •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
排除标准
- •Vasculature in the right extremity precluding 6Fr sheath radial or brachial access
- •Inadequate circulation to the right extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse
- •Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
- •Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
- •Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
- •Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+)
- •Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease)
- •Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
- •Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy
- •Hemodynamic instability requiring inotropic support or mechanical heart assistance.
- •Need for emergency surgery for any reason
- •Hypertrophic cardiomyopathy with or without obstruction
- •Severe ventricular dysfunction with LVEF ≤20%
- •Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
- •Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant CEA/stenting
- •Subject has undergone carotid stenting or carotid endarterectomy within the previous 6 weeks
- •Active peptic ulcer or upper GI bleeding within the prior 3 months
- •A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated
- •Recent (within 6 months) CVA or a TIA
- •Renal insufficiency (creatinine > 3.0 mg/dL or GFR < 30) and/or renal replacement therapy at the time of screening
- •Life expectancy < 12 months due to non-cardiac co-morbid conditions
- •Subjects in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
- •Subjects who have active bacterial endocarditis or other active infections
- •Currently participating in an investigational drug or another device study
- •Subjects who have a planned treatment with any other investigational device or procedure during the study follow-up period (90 days)
- •Subject with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation during the study follow-up period (90 days)
- •Any subject with a balloon valvuloplasty (BAV) within 30 days of the procedure
- •Subject had active major psychiatric disease
- •Subject has severe visual, auditory, or learning impairment and who are unable to comprehend English and therefore unable to be consented for the study
- •Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
- •Angiographic
- •Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel System access and insertion
- •Subject whose brachiocephalic or left carotid artery reveals significant stenosis, calcification, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium
- •Magnetic Resonance Imaging
- •Subject Body Mass Index (BMI) precluding imaging in scanner
- •Contraindications to MRI (subjects with any implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure)
- •Planned implantation of a pacemaker or defibrillator implantation after TAVR
- •Claustrophobia
- •Known allergy to gadolinium or contrast agent
研究组 & 干预措施
Test Arm
干预措施: Cerebral Protection System-The SENTINEL System with TAVR (Device)
Control Arm
干预措施: TAVR (Device)
Safety Arm
干预措施: Cerebral Protection System-The SENTINEL System with TAVR (Device)
结局指标
主要结局
Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure.
时间窗: Day 2-7 Post-Procedure
Total new lesion volume is defined as the sum of all diffusion-positive new cerebral lesions in post-TAVR DW-MRI relative to the pre-TAVR DW-MRI scans. Protected territories are defined as brain territories uniquely perfused by the vessels protected by the Sentinel System, namely the left and right carotid arteries, and the right vertebral artery.
Patients With Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days
时间窗: 30 Days Post-Procedure
Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3 within 72 hours or discharge, whatever occurs first) at 30 days compared to a historical performance goal of 18.3%.
次要结局
- Captured Debris Histopathology (Observational)(Post-procedure)