Clinical Trial in China for Aortic Valve Stenosis

Study Overview
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Brief Summary
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The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis disease who are at high or prohibitive surgical risk.

Detailed Description
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This study is a prospective, multicenter, single-arm, clinical study.

Official Title
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Efficacy and Safety of the J-Valve Transcatheter Aortic Valve Replacement System in Patients With Aortic Stenosis Disease

Conditions
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Diseases of Aortic Valve, Aortic Stenosis Disease

Intervention / Treatment
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* Device: Transcatheter aortic valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 65; Patients with symptomatic aortic valve regurgitation diseases, and New York Heart Association (NYHA) ≥ II; Subject must have Society of Thoracic Surgeons (STS) score ≥8% or have been evaluated as inoperable by the surgical team [defined as rate of death #50% within 30 d post-surgery or accompanied with irreversible occasions of other factors prevent surgeries (such as heavily calcified (porcelain) ascending aorta, weakness, chest malformation, liver dysfunction, pulmonary dysfunction and so on ); (Note: age of inoperable patients can be expanded to ≥ 50); Aortic valve anatomy is suitable for TAVR evaluated by the investigators; Patients who can sign informed consent form, and are willing to accept relevant examinations and clinical follow-ups. Exclusion Criteria: Active endocarditis; Acute myocardial infarction or coronary revascularization occurred within 1 month before procedure; Cerebrovascular accident (CVA) occurred within 30 days before procedure; The echocardiogram indicates the presence of mass, thrombus or vegetation in left ventricle and left atrium; Hypertrophic obstructive cardiomyopathy; Other valve diseases that need interventions; Previous aortic valve implantation (mechanical or biological); Allergic to Nickel-titanium alloys or contrast agents or cattle-originated products; Known allergy or contraindication to all anticoagulation, or anticoagulation can not be used during the TAVR; In presence one of the following (from selection to the day of procedure index): a other diseases that may shorten life expectancy to less than 12 months (recurrent or metastatic cancer, congestive heart failure); b drug abuse (such as cocaine, heroin and so on); c planned additional operations that may result in incompliance or data confusion; Stenosis of common carotid artery, internal carotid artery or vertebral artery #70%; Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%; Hepatic encephalopathy or acute active hepatitis; Receiving hemodialysis; Bleeding tendency or history of coagulopathy or refuse to receive transfusion; Active gastrointestinal (GI) ulcer or bleeding; Severe dementia; Patients who need emergency surgery for any reason; Patients are participating in other drugs or medical devices clinical trial; Pregnant or plan to be pregnant, or are taking estrogen or estrogen-like drugs (Women suspected of pregnancy must have a negative serum or urine test for human villous gonadotropin prior to enrollment in the study); Other inappropriate occasions according to the investigators.

Ages Eligible for Study
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Minimum Age: 65 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: Experimental: Treatment<br>Device: J-Valve® valve delivery system， Transvascularized biological aortic valve system | Device: Transcatheter aortic valve replacement<br>* Transcatheter aortic valve replacement system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative all-cause mortality | All-cause mortality within 12 months of TAVR procedure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success | No operative death;The instrument was placed in the correct anatomical position, and the delivery assembly was successfully entered and withdrawn;No device-related surgical or interventional intervention (other than permanent pacemaker implantation) | 30 days | 
| Procedural success | Technical success,No death,No device-related surgical or interventional intervention (except permanent pacemaker implantation),The artificial aortic valve achieved the expected value (mean transaortic pressure difference < 20mmHg or transaortic flow velocity < 3m/s; No moderate or greater artificial aortic regurgitation or perivalvular leakage) | : immediate post-surgical | 
| Evaluation of bioprosthetic valve and cardiac function Evaluation of bioprosthetic valve and cardiac function Evaluation of bioprosthetic valve and cardiac function | Echocardiography was used to evaluate aortic valve function and cardiac function | 30 days, 6 months, 12 months | 
| Functional Improvement of heart ( NYHA） | NYHA classification of cardiac function was evaluated after operation | 30 days, 6 months, 12 months | 
| Quality of life（KCCQ） | Evaluation of postoperative Quality of life score improvement (KCCQ) | 30 days, 6 months, 12 months | 
| Major cardiovascular and cerebrovascular adverse events (MACCE) | Major adverse cardiovascular and cerebrovascular events (MACCE) included mortality, stroke, myocardial infarction, reoperation, arrhythmia, and conduction block. | before discharge/7days, 30 days, 6 months, 12 months | 
| Myocardial infarction | Incidence of myocardial infarction | before discharge/7days, 30 days, 6 months, 12 months | 
| Stroke | Grades include ischemic stroke (including transient ischemic attack, TIA) and hemorrhagic stroke Grades included ischemic stroke (including transient ischemic attack, TIA) and hemorrhagic stroke; Definitions included disabling stroke (modified Rankin score ≥2 at 90 days after stroke with an increase of >1 point) and nondisabling stroke (modified Rankin score <2 at 90 days after stroke with no increase in score). Stroke events should be recorded and the causes analyzed in detail. | before discharge/7days, 30 days, 6 months, 12 months | 
| Major bleeding (life-threatening or crippling) | Severe bleeding: BARC bleeding was defined as type 3a and above | before discharge/7days, 30 days, 6 months, 12 months | 
| Acute kidney injury | The incidence of AKIN stage 2 and above events was recorded. | before discharge/7days, 30 days, 6 months, 12 months | 
| Conduction block and malignant arrhythmia | The incidence of conduction block and malignant arrhythmias | before discharge/7days, 30 days, 6 months, 12 months | 
| Permanent pacemaker implantation | Permanent pacemaker implantation rate | before discharge/7days, 30 days, 6 months, 12 months | 
| TAVI related complications | These include conversion to surgery, accidental mechanical cardiopulmonary assistance, coronary occlusion, ventricular septal perforation, mitral valve damage or loss of function, cardiac tamponade, endocarditis, valve thrombosis, valve ectopic (displacement, embolization, misrelease), aortic dissection, aortic root rupture, and peripheral vascular complications. | before discharge/7days, 30 days, 6 months, 12 months | 
| Device defects | Incidence of device defects | intraoperative | 
| The incidence of adverse events The incidence of adverse events | Incidence of adverse events | 12 months | 
| The incidence of serious adverse events | Incidence of serious adverse events | 12 months |