NCT03025971CompletedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- JC Medical, Inc.
- Enrollment
- 107
- Locations
- 3
- Primary Endpoint
- All-cause Mortality
Study Overview
Brief Summary
A prospective, multicenter, nonrandomized, single-arm, clinical study.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed Informed Consent
- •Age ≥18years of age
- •Presents with symptomatic aortic stenosis and/or aortic regurgitation, as well as NYHA rating of NYHA ≥ II
- •Has undergone the diagnosis of at least one interventional cardiologist and two cardiac surgeons: the patients are contraindicated for traditional open heart valve replacement surgery (defined as 30 days post-op mortality risk >50%, irreversible complications, or other influential post-operative factors [such as severe calcification in the ascending aorta and aortic valve, weak physical condition, chest deformities, severe liver diseases, severe lung diseases, etc.] or high risk for surgery (LogEuroSCORE≥20% and or STS≥8)
- •Has a diagnosis from at least one interventional cardiologist and two cardiac surgeons that the patient may benefit from a valve implantation
- •Severe aortic stenosis with electrocardiography results as follows: mean transvalvular pressure gradient ≥40 mmHg or maximal forward aortic blood flow velocity of ≥4.0 m/s, aortic valve area < 0.8 cm2 (or AVA index < 0.5 cm2/m2); and/or severe aortic regurgitation, electrocardiography results show symptomatic moderate regurgitation or severe regurgitation
- •Without severe pulmonary arterial hypertension
- •The patient is willing to cooperate with all follow-up visits.
- •Anatomical 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).
Outcomes
Primary Outcomes
All-cause Mortality
Time Frame: 12 months
Secondary Outcomes
- Cardiac function improvement(30 days, 6 months, 12 months and annually up to 5 years)
Investigators
Study Sites (3)
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