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Full eligibility criteria for NCT03025971
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Aortic annulus >19mm and <29mm, standardized using cardiac CT measurements;
Ascending aortic diameter <50mm at the sinotubular junction.
Patients with infection or who have any sign of infection
Previous history of endocarditis or patients with active endocarditis
Incidence of acute myocardial infarction within the past 30 days (Q-wave MI, or non Q-wave MI with creatine kinase, an increase in troponin T)
Any cardiac mass discovered during echocardiography, left ventricular or atrial thrombosis
Suffering from uncontrollable atrial fibrillation
Hereditary hypertrophic cardiomyopathy
Mitral or tricuspid valve insufficiency (Class Ⅱ regurgitation or greater)
Has previously undergone aortic valve implantation (mechanical valve or biological valve frame)
Is known to be allergic to contrast agents, aspirin, heparin, ticlopidine medications, nitinol or porcine products
Is known to be contraindicated for or is allergic to all anti-coagulants or is unable to use anti-coagulants during the study
Is known to have one of the following conditions (according to evaluations beginning from screening through the day of the procedure):
Other diseases that may reduce the life expectancy to less than 12 months (such as clinically recurrent or metastatic cancer, congestive heart failure, etc.)
Currently has drug abuse problems (such as alcohol, cocaine, heroin, etc.)
Plans to undergo surgery that may result in non-compliance with the study protocol or that may cause confusion in data interpretation.
Has experienced a cerebrovascular accident (CVA) within the last 6 months
Patients suffering from stenosis of the carotid, internal carotid, or vertebral arteries (70%)
White cell count ＜3×109/L, platelet count＜50×109/L
Hemoglobin ＜90 g/L
Severely lowered left ventricular function, left ventricular ejection fraction < 20 %
Aortic aneurysm in the abdomen or chest
Hepatic encephalopathy or acute active hepatitis
Currently undergoing dialysis or baseline creatine levels >2.5 mg/dL (221μmoI/L)
Prone to bleeding, has a history of clotting disorders or refuses blood transfusions
Active ulcer or active gastrointestinal (GI) bleeding
Suffering from nervous system diseases that severely influence the patients' ability to move or to perform daily activities
Patients with severe dementia
Any reason for emergent surgery
Taking part in other clinical trials for pharmaceuticals or medical devices
Those who are pregnant, plan to become pregnant, or who are taking estrogen or estrogen-like drugs (women suspected of being pregnant must test negative on a urine pregnancy test or for chorionic gonadotropin serum).
All locations for NCT03025971
View full eligibility
Tris trial is registered with FDA with number: NCT03025971. The sponsor of the trial is JC Medical, Inc. and it is looking for 107 volunteers for the current phase.
Official trial title: Efficacy and Safety Evaluation for The Interventional Aortic Valve Bioprosthesis and Delivery System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation With Elevated Surgical Risk
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