NCT06034028进行中（未招募）不适用
J-Valve TF Early Feasibility Study
JC Medical, Inc., an affiliate of Edwards Lifesciences LLC18 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年10月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 18
- 主要终点
- Number of patients that do not experience death or disabling stroke
研究概览
简要总结
The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.
详细描述
The EFS is a prospective, single arm, multi-center, interventional study that will enroll up to 25 subjects in up to 15 centers in the United States and/or Canada and report the primary endpoint of all-cause death or disabling stroke at 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patient has symptomatic (NYHA FC ≥ IIs) severe (≥3+) native AR (per 2020 ACC/AHA Guideline for Management of Patients with Valvular Heart Disease) diagnosed by echocardiography. Patients will be assessed according to the current American Society of Echocardiography Guidelines for Non-invasive Evaluation of Native Valve Regurgitation. Transesophageal echocardiography (TEE) or cardiac MRI (CMR) will be used in case of indeterminant AR;
- •Patient is judged by a multi-disciplinary heart team to be at high risk for surgery, based on the ACC/AHA guidelines for management of patients with valvular heart disease: STS-PROM score ≥8%, or if <8%, significant co-morbidities that are not captured by the STS-PROM score (e.g., ≥2 frailty indices, 1 to 2 major organ system compromise, the presence of certain procedure-specific factors that affect surgical mortality), based on the consensus of a multi-disciplinary heart team;
- •Patient has suitable anatomy for J-Valve implantation (see anatomic exclusions below);
- •Patient or the patient's legal representative has provided written informed consent;
- •Patient or patient's legal representative agrees to comply with all required post-procedure follow-up visits.
排除标准
- •Patients that are at prohibitive surgical risk (predicted risk for mortality or major morbidity at 30 days >50% with SAVR);
- •Mixed aortic valve disease, defined as coexistence of > moderate aortic valve stenosis with severe AR;
- •Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticlopidine, clopidogrel, Nitinol (Nickel, Titanium, Aluminum) or sensitivity to contrast media, which cannot be adequately premedicated;
- •Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
- •Active infection, including infective endocarditis;
- •Liver failure (Child-C);
- •Reduced left ventricular function with left ventricular ejection fraction (LVEF) <25% as measured by resting echocardiogram;
- •Uncontrolled atrial fibrillation (e.g., resting heart rate >120 bpm);
- •Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
- •Renal insufficiency (eGFR <25) and/or end stage renal disease requiring chronic dialysis;
- •Pulmonary Hypertension (systolic pressure ≥2/3 of systemic);
- •Severe Chronic Obstructive Pulmonary Disease (COPD) = requiring steroids or requiring continuous home O2
- •Severe mitral or severe tricuspid regurgitation or stenosis;
- •Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of treatment;
- •Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
- •Recent (within 6 months of treatment) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
- •Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
- •Untreated multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery;
- •Evidence of acute myocardial infarction within 1 month of intended procedure;
- •PCI within 30 days of intended procedure;
- •Estimated life expectancy of less than 24 months due to associated (excluding cardiac) co-morbid conditions;
- •Left Ventricular Assist Device (LVAD) dependent;
- •Participating in another study that may influence the outcome of this study;
- •Need for emergency surgery for any reason;
- •Previous aortic bioprosthesis or mechanical implant.
- •Anatomic Exclusion Criteria:
- •Ascending Aortic diameter >5 cm;
- •Aortic Annulus Perimeter <57 mm or >104 mm;
- •Access vessel minimum diameter <5.5 mm;
- •LVEDD >75 mm;
- •Bicuspid aortic valve disease;
- •Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk.
- •Abdominal aortic aneurysm ≥ 4.0 cm;
- •Aorto-iliac disease requiring intervention to facilitate delivery of access sheath;
- •Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, descending aorta, ascending aorta, aortic arch, and aortic angle >80⁰. In most cases, this exclusion will be identified and assigned following review by the multi-disciplinary Screening Committee.
结局指标
主要结局
Number of patients that do not experience death or disabling stroke
时间窗: 30 days after the valve procedure
Freedom from death or disabling stroke Disabling stroke is evaluated using a standardized scale
次要结局
- Number of patients and procedures achieving technical success(At point patient exits the procedure room)
- Number of patients meeting clinical efficacy outcome at 4 years(4 years after the valve procedure)
- Number of patients meeting clinical efficacy outcome at 5 years(5 years after the valve procedure)
- Number of patients with a safety-related event outcome(30 days after the valve procedure)
- Number of patients meeting clinical efficacy outcome at 2 years(2 years after the valve procedure)
- Number of patients meeting clinical efficacy outcome at 3 years(3 years after the valve procedure)
- Number of patients achieving long-term clinical efficacy for valve function(5 years after the valve procedure)
- Number of patients and procedures achieving device success(30 days after the valve procedure)
- Number of patients experiencing success(1 year after the valve procedure)
研究者
研究点 (18)
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