Aortic Valve Stenosis With Insufficiency
JC Medical, Inc.
A prospective, multicenter, nonrandomized, single-arm, controlled target value study, designed to include no less than 82 patients in at least two (2) clinical centers in China.
- Device: J-Valve Transcatheter Aortic valve replacementTransapical Transcatheter Aortic Valve Replacement
|Ages eligible for Study||18 Years and older|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||No|
- 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).
To evaluate the safety and efficacy of the J-Valve Ausper system for the treatment of patients with severe aortic stenosis and/or aortic regurgitation with elevated risk for surgery. A prospective, multicenter, nonrandomized, single-arm, controlled target value study, designed to include no less than 82 patients in at least two (2) clinical centers in China.
active not recruiting
28 February, 2014
16 January, 2017