A Prospective, Single Arm, FIH Study to Evaluate the Safety and Feasibility of the CAPTIS Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Safety - Occurrence of MACCE
研究概览
简要总结
This is a First in Human study with the Filerlex CAPTIS device designed to demonstrate the safety and feasibility of the device in subjects undergoing Transcatheter Aortic Valve Replacement (TAVR)
详细描述
This is a prospective, multi center, single arm, FIH safety and feasibility study enrolling up to 20 patients. Patients undergoing clinically indicated TAVR who comply with the study inclusion/exclusion criteria will be enrolled to have embolic protection with the CAPTIS® Device during the TAVR procedure.
Screening activities will include initial screening by the site, analysis of patient CT scan by the sponsor and core-lab, and review of the clinical and imaging data by an eligibility committee to confirm that all inclusion/exclusion criteria are met. Final eligibility for study enrollment is then determined by the investigator in the cardiac catheterization laboratory.
Enrolled patients will undergo safety assessment during the procedure, post-procedure, and at 30 days post-procedure; Feasibility evaluation will be assessed during procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •The patient must be ≥18 years of age.
- •Patient has clinical indications for TAVR procedure.
- •TAVR procedure planned with femoral artery access site
- •TAVR device approved for use in the US, Europe or Israel
- •Femoral and iliac artery with a minimal luminal diameter of at least 6 mm
- •Descending Aorta diameter of 20 to 27mm measured 10cm from the left subclavian, determined by CT scan analysis
- •The distance between the innominate and left-subclavian arteries (including their lumens) is less than 65mm
- •Patient is willing to comply with protocol-specified preprocedure and follow-up evaluations.
- •The patient has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the clinical site.
排除标准
- •Pregnant or nursing female patients. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test
- •Hemodialysis shunt, graft, or arterio-venous fistula involving the lower extremity vasculature
- •Blood dyscrasias: WBC <5000/microliter, Hb <10.0 mg/dL, PLT <100,000/microliter, history of bleeding diathesis, coagulopathy, or conditions associated with increased thrombogenicity
- •Hemodynamic instability requiring pharmacological or mechanical circulatory support. Patient in whom hemodynamic instability is expected or at increased risk, will also be excluded.
- •Any surgery or procedure (including endovascular) planned for the 30 days post TAVR
- •Severe left-ventricle dysfunction with LVEF ≤30%
- •Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
- •Active or recent bacterial endocarditis
- •Active peptic ulcer or upper GI bleeding within the prior 3 months
- •A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, ticagrelor, or contrast media, which cannot be adequately pre-medicated or replaced by an alternative agent
- •Renal insufficiency (GFR < 30). Patients on renal replacement therapy (dialysis) can be enrolled into the study.
- •Life expectancy < 12 months due to non-cardiac comorbid conditions
- •Patients who refuse blood transfusion
- •Chronic or persistent atrial fibrillation, frequent recurring atrial fibrillation, and patients with planned ablation for atrial fibrillation
- •Currently participating in another investigational drug or device study
- •Patient is otherwise not appropriate for the study as determined by the investigator or the Eligibility Committee
- •Prior CVA or a TIA
- •Patient has undergone carotid stenting or carotid endarterectomy within the previous 6 months
- •Patient has active major psychiatric disease that prevent a conscious consent
- •Patient with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic deficit or known structural brain abnormalities
- •Severe tortuosity or luminal diameter of less than 6 mm of the femoral or iliac arteries
- •Excessive tortuosity or calcification or atherosclerosis of any segment of the aorta and iliac arteries
- •Patient whose innominate, carotid, or subclavian arteries reveals significant stenosis, ostial calcification, ectasia, dissection, or aneurysm at the ostium
结局指标
主要结局
Safety - Occurrence of MACCE
时间窗: 72 hours
Occurrence of all MACCE at 72 hours post procedure, with MACCE defined as all death and all cerebrovascular events (all TIA and stroke).
Safety - Device related complications
时间窗: 72 hours
Number of device related complications \[at 72 hours\]
次要结局
- Secondary Safety - Occurrence of MACCE(30 days)
- Secondary Safety - Acute Kidney Injury(72 hours)
- Device feasibility - Histopathologic examination of debris captured and removed by the device(Day 0)
- Technical Device Performance - the ability to deploy and retrieve the device without device malfunction(Day 0)