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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 (NCT03025971)

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 replacement
    Transapical Transcatheter Aortic Valve Replacement
    • TAVI
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Inclusion Criteria:
  • Aortic annulus >19mm and <29mm, standardized using cardiac CT measurements;
  • Ascending aortic diameter <50mm at the sinotubular junction.
Exclusion Criteria:
  • 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
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