NCT01932099Unknown2 期
The Direct Flow Medical TranScatheter Aortic Valve RepLacement System US Feasibility Trial
Direct Flow Medical, Inc.11 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 11
- 主要终点
- Freedom from all cause mortality/Device success
研究概览
简要总结
A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve system. This is for people with severe aortic stenosis who are not well enough to undergo a surgical repair. The delivery of this device is done via the femoral artery.
详细描述
The Direct Flow Medical Transcatheter Aortic Valve System is indicated for symptomatic patients who require replacement of their native aortic valve and have a predicted operative mortality or serious morbidity risk of equal or greater 50% at 30 days with surgical aortic valve replacement or are deemed unsuitable for surgery.
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
- •The patient has severe senile degenerative aortic valve stenosis determined by resting or dobutamine stress echocardiogram and Doppler, or simultaneous pressure recordings at cardiac catheterization 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/m
- •The patient has moderate to severe symptoms from aortic valve stenosis (NYHA Functional Class ≥III).
- •The patient must have a predicted risk of operative mortality or serious irreversible morbidity of >50% at 30 days, or be deemed not suitable for surgery for other reasons. This conclusion shall be based on consensus of one cardiologist and two cardiac surgeons at the investigational site after careful consideration of the patient's STS risk score and co-morbidities, and after at least one of the surgeons participating in the decision has personally examined the patient.
- •The patient been informed of the nature of the study, agrees to its provisions, is willing to comply with protocol-specified follow-up evaluations and has provided written informed consent, approved by the appropriate IRB.
排除标准
- •Left ventricular ejection fraction (LVEF) <20% determined by resting echocardiogram
- •Patients with an acute MI within 30 days preceding the index procedure.
- •Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the study procedure
- •Patients with impaired renal function (estimated Glomerular Filtration Rate [eGFR] <20cc/min, calculated from serum creatinine by the Cockcroft-Gault formula)
- •Patients with a platelet count of <50,000 cells/mm³ or a WBC < 1000 cells/mm³ within 7 days prior to index procedure.
- •Patients with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion.
- •Patients who have received any organ transplant or are on a waiting list for any organ transplant.
- •Patients with known other medical illness (e.g. carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease) or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a life expectancy of less than one year, or expectation that patient will not improve despite treatment of aortic stenosis.
- •Patients with known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, and/or contrast sensitivity that cannot be adequately pre-medicated.
- •Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months.
- •Patients with an active gastrointestinal (GI) bleeding within the prior 6 months.
- •Patients presenting with hemodynamic instability or cardiogenic shock defined by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
- •Patients who have a planned treatment with any other investigational device or procedure during the study period, or who are currently participating in an investigational drug or another device trial
- •Any planned surgical, percutaneous coronary or peripheral procedure to be performed prior to the 30 day follow-up from the TAVR procedure.
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Trans-esophageal echocardiography (TEE) is contraindicated
- •Active endocarditis or sepsis within 6 months prior to the study procedure
- •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)
- •Congenital bicuspid or unicuspid valve determined by echocardiography
- •Prior aortic or mitral valve surgery or pre-existing prosthetic heart valve in any position
- •Native valve annulus diameter is <19mm or >26mm determined by the screening CT scan
- •Extreme asymmetrical calcification of the native aortic valve determined by the screening CT scan
- •Echocardiographic evidence of intra-cardiac mass, thrombus, vegetation, or spontaneous echo contrast in the left atrium
- •>3+ aortic regurgitation, mitral regurgitation or tricuspid regurgitation
- •Moderate to severe mitral stenosis
- •Thoracic aortic aneurysm (TAA) or abdominal aortic aneurysm (AAA) >5.0 cm
- •Presence of an endovascular stent graft for treatment of AAA or TAA 28 Hypertrophic obstructive cardiomyopathy
- •Patients with severe peripheral arterial disease that precludes sheath vascular access (e.g. luminal diameter less than 6.5 mm, severe obstructive calcification or severe tortuosity)
结局指标
主要结局
Freedom from all cause mortality/Device success
时间窗: 6 months post procedure
Absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomic location AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient less than 20 mmHg or peak velocity less than 3m/s, AND no moderate or severe prosthetic valve regurgitation.
次要结局
- Time-related Valve Safety(30 days, 6 months and annually at 1 to 5 years)
- Clinical Endpoints(30 days, 6 months and annually at 1 to 5 years.)
- Early Safety(30 Days)
- Clinical Efficacy(6 months,and annually at 1 to 5 years)
研究者
研究点 (11)
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