Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis

Study Overview
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Brief Summary
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The purpose of the study is to determine the safety and performance of the Direct Flow Medical study valve and delivery procedure.

Detailed Description
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Prospective, multicenter, non-randomized clinical trial of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the treatment of severe aortic stenosis

Official Title
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Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Replacement of the Aortic Stenotic Valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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 Exclusion Criteria 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)

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous Aortic Valve 18F System<br>Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients with Severe Aortic Stenosis. | Device: Replacement of the Aortic Stenotic Valve<br>* Treatment for patients with Severe Aortic Stenosis.<br>* Other names: TAVR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from all-cause mortality from procedure to 30 days |  | Procedure to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success at procedure completion | Device success is assessed at the completion of the study procedure based on TEE | At procedure completion |