NCT01475799Unknown不适用
Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis
Direct Flow Medical, Inc.20 个研究点 分布在 5 个国家目标入组 112 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 112
- 试验地点
- 20
- 主要终点
- Freedom from all-cause mortality from procedure to 30 days
研究概览
简要总结
The purpose of the study is to determine the safety and performance of the Direct Flow Medical study valve and delivery procedure.
详细描述
Prospective, multicenter, non-randomized clinical trial of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the treatment of severe aortic stenosis
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
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All candidates for the study must meet the following inclusion criteria:
- •Severe aortic valve stenosis determined by echocardiogram and Doppler, defined as: mean gradient >40 mmHg or peak jet velocity >4.0 m/s and an aortic valve area ≤0.8 cm2 or aortic valve area index ≤0.5 cm2/m2
- •Symptomatic aortic valve stenosis demonstrated by angina, congestive heart failure, NYHA Functional Class ≥ II, or syncope
- •Patient is an extreme risk candidate for open surgical aortic valve repair such that the site Investigators (interventional cardiologist and cardiothoracic surgeon) agree that medical factors preclude operation, based on the conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement due to the patient's co-morbidities (such as, but not limited to, severe COPD, porcelain aorta, previous thorax irradiation) or logistic EuroSCORE ≥ 20
- •≥ 70 years old
- •Patient has been informed of the nature of the study and has provided written informed consent
- •Patient and treating physician agree that the patient will return for all required post-procedure follow-up visits
排除标准
- •Candidates will be excluded from the study if any of the following criteria are present:
- •Patient is a surgical candidate for aortic valve replacement
- •Congenital bicuspid or unicuspid valve determined by echocardiography
- •Native valve annulus diameter is <17mm or >22mm determined by the screening CT scan
- •Extreme asymmetrical calcification of the native aortic valve determined by the screening CT scan
- •Native valvular or peripheral vascular anatomy is not appropriate for the DFM bioprosthesis and 18F delivery system
- •Left ventricular ejection fraction (LVEF) <30% determined by resting echocardiogram
- •Evidence of an acute myocardial infarction (Refer to Definitions in Section 8) within 30 days prior to the study procedure
- •Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the study procedure
- •Any planned surgical or percutaneous coronary or peripheral procedure to be performed during the study procedure or prior to 30 day follow-up visit
- •Need for emergency surgery for any reason
- •Untreated clinically significant ( > 70% obstruction) coronary artery disease requiring revascularization
- •Prior aortic or mitral valve surgery
- •Pre-existing prosthetic heart valve in any position
- •Mitral insufficiency greater than moderate determined by resting echocardiography
- •Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
- •Thoracic aortic aneurysm (TAA)
- •Abdominal aortic aneurysm (AAA) >4.5 cm
- •Presence of an endovascular stent graft for treatment of AAA or TAA
- •Hypertrophic cardiomyopathy
- •Hemodynamic instability (e.g. requiring inotropic support)
- •Trans-esophageal echocardiography (TEE) is contraindicated
- •Renal insufficiency (creatinine > 3.0 mg/dL) and/or end-stage renal disease requiring dialysis at the time of screening
- •Active endocarditis or sepsis within 6 months prior to the study procedure
- •Stroke or transient ischemic attack (TIA) within 6 months prior to the study procedure
- •Cardiogenic shock within 30 days prior to the study procedure
- •Active peptic ulcer or upper GI bleeding within 3 months prior to the study procedure
- •Leukopenia (WBC <3000/mm³), acute anemia (Hb <9 g/dL), or thrombocytopenia (platelet count <100,000 cells/mm3)
- •History of bleeding diathesis or coagulopathy or refusal of blood transfusions
- •A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, or sensitivity to contrast media, which cannot be adequately pre-medicated
- •Currently participating in an investigational drug or another device trial
- •Previously enrolled in this study
- •Patient refusal of surgery
- •Life expectancy thought to be <12 months
- •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)
结局指标
主要结局
Freedom from all-cause mortality from procedure to 30 days
时间窗: Procedure to 30 days
次要结局
- Device Success at procedure completion(At procedure completion)
研究者
研究点 (20)
Loading locations...
相似试验
招募中
不适用
FreeFlow Percutaneous Atrial Septal Shunt for IPAHPulmonary Arterial HypertensionNCT06605794Shanghai Zhongshan Hospital30
Unknown
2 期
TranScatheter Aortic Valve RepLacement System US Feasibility TrialAortic Valve StenosisNCT01932099Direct Flow Medical, Inc.30
已完成
不适用
Clinical Investigation to Assess Safety and Performance of Dermal Filler of Hyaluronic AcidSkin FoldsWrinkleNCT05450380Mesoestetic Pharma Group S.L.50
终止
不适用
Study on Fistuloplasty Using Flow Measurement GuidanceEnd Stage Renal Failure on DialysisRenal FailureNCT01643733Richard Lindsay26
招募中
不适用
Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening IschemiaCritical Limb-Threatening IschemiaPeripheral Arterial DiseaseDiabetic FootNCT06277362EndoCore Lab s.r.l.50