NL-OMON42354已完成不适用
Cerebral Protection of Acute Embolic Burden During Transcatheter Aortic Valve Implantation * A Randomized Diffusion-Weighted MRI Study (CP-11134) - SENTINEL-L Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Severe symptomatic aortic valve stenosis
- •2. Compatible anatomy for Sentinel and LV1 Systems:
- •o Sentinel System: left common carotid artery (6.5 * 10 mm) and brachiocephalic artery (9 * 15 mm) diameters
- •o LV1 System: left subclavian artery (7.0 * 12.0 mm) diameter
- •3. Subject eligible for transfemoral TAVI access with planned implantation of Boston Scientific Lotus Valve System
排除标准
- •1. Contraindications to TAVI per heart team
- •2. Current or recent cerebrovascular accident (stroke, TIA) <6 months
- •3. Transapical, direct aortic or subclavian TAVI access
- •4. Carotid stenting or endarterectomy in last 6 weeks
- •5. Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant Carotid Endarterectomy / stenting
- •6. History of atrial fibrillation (AF) including:
- •o Persistent AF (defined as continuous AF which is sustained beyond seven days, or lasting greater than 48 hours and less than seven days but necessitating pharmacologic or electrical cardioversion), or
- •o History of Paroxysmal AF during the previous 30 days. Paroxysmal AF is defined as recurrent AF (>2 episodes) that terminates spontaneously within 7 days. Episodes of AF of < 48 hours* duration that are terminated with electrical or pharmacologic cardioversion are also classified as paroxysmal AF episodes.;7. Subject with active endocarditis or other systemic infection
- •8. Prior aortic valve replacement
- •9. Concomitant procedure with TAVI such as CABG, PCI, etc.
- •10. Claustrophobia
- •11. Contraindications to MRI (subjects with any non-MRI compatible 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 non-MRI compatible pacemaker or implantable cardioverter defibrillator after TAVR
- •12. Allergy to intravascular contrast agents
- •13. Immobilization or other morbidity with life expectancy < 1 year
- •14. Inability to accommodate a 6F sheath (Sentinel) or 5F (LV1) into the right and left radial or brachial arteries respectively
- •15. Inadequate circulation to the right or left extremity as evidenced by signs of artery occlusion (modified Allen*s test) or absence of radial/brachial pulse
- •16. Subjects with vascular tortuosity or anatomy that would preclude the safe introduction and placement of the Sentinel System and/or the LV1 System per anatomy screening process
- •17. Lack of written informed consent
- •18. Patients in whom anticoagulant and antiplatelet therapy is contraindicated
- •19. Patients with uncorrected bleeding disorders
- •20. Patients with compromised blood flow to the left upper extremity
- •21.Patient who has arterial stenosis >70% in the left subclavian artery
- •22.Patient whose left subclavian artery reveals significant stenosis, ectasia, dissection, or aneurysm between the aortic ostium and the left vertebral artery
- •23. Patient is pregnant or lactating
- •24. Patients requiring left axillary/subclavian access for transcatheter aortic valve implantation
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